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Institutional UsersAccess through Ovid® Not a Subscriber?Buy Subscribe Request Permissions You can read the full text of this article if you: Log In Access through Ovid Department: i.v.essentials ROSENTHAL, KELLI RN, BC, ANP, APRN, BC, CRNI, MS President and CEO, ResourceNurse Continuing Education, Inc., Long Beach, N.Y. Past President, Association for Vascular Access, Clinton, Miss. Nursing Made Incredibly Easy!: July 2007 - Volume 5 - Issue 4 - p 11-13 doi: 10.1097/01.NME.0000278465.32401.31
Cochrane Database Syst Rev. 2019; 2019(1): CD007798. Monitoring Editor: Joan Webster, Griffith University, National Centre of Research Excellence in Nursing, Centre for Health Practice Innovation, Menzies Health Institute Queensland, 170 Kessels Road, BrisbaneQueenslandAustralia, 4111 The University of Queensland, School of Nursing and Midwifery, BrisbaneQueenslandAustralia Royal Brisbane and Women's Hospital, Nursing and Midwifery Research Centre, Butterfield Street, HerstonQueenslandAustralia, 4029 Queensland University of Technology, School of Public Health and Social Work, Institute of Health and Biomedical Innovation, Kelvin Grove Campus, 69 Musk Ave, BrisbaneQueenslandAustralia, 4059 Griffith University, Alliance for Vascular Access Teaching and Research (AVATAR), Menzies Health Institute Queensland, BrisbaneAustralia, Queensland 4029 AbstractBackgroundUS Centers for Disease Control guidelines recommend replacement of peripheral intravenous catheters (PIVC) no more frequently than every 72 to 96 hours. Routine replacement is thought to reduce the risk of phlebitis and bloodstream infection. Catheter insertion is an unpleasant experience for patients and replacement may be unnecessary if the catheter remains functional and there are no signs of inflammation or infection. Costs associated with routine replacement may be considerable. This is the third update of a review first published in 2010. ObjectivesTo assess the effects of removing peripheral intravenous catheters when clinically indicated compared with removing and re‐siting the catheter routinely. Search methodsThe Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase and CINAHL and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 18 April 2018. We also undertook reference checking, and contacted researchers and manufacturers to identify additional studies. Selection criteriaWe included randomised controlled trials that compared routine removal of PIVC with removal only when clinically indicated, in hospitalised or community‐dwelling patients receiving continuous or intermittent infusions. Data collection and analysisThree review authors independently reviewed trials for inclusion, extracted data, and assessed risk of bias using Cochrane methods. We used GRADE to assess the overall evidence certainty. Main resultsThis update contains two new trials, taking the total to nine included studies with 7412 participants. Eight trials were conducted in acute hospitals and one in a community setting. We rated the overall certainty of evidence as moderate for most outcomes, due to serious risk of bias for unblinded outcome assessment or imprecision, or both. Because outcome assessment was unblinded in all of the trials, none met our criteria for high methodological quality. Primary outcomes Seven trials (7323 participants), assessed catheter‐related bloodstream infection (CRBSI). There is no clear difference in the incidence of CRBSI between the clinically indicated (1/3590) and routine change (2/3733) groups (risk ratio (RR) 0.61, 95% confidence interval (CI) 0.08 to 4.68), low‐certainty evidence (downgraded twice for serious imprecision). All trials reported incidence of thrombophlebitis and we combined the results from seven of these in the analysis (7323 participants). We excluded two studies in the meta‐analysis because they contributed to high heterogeneity. There is no clear difference in the incidence of thrombophlebitis whether catheters were changed according to clinical indication or routinely (RR 1.07, 95% CI 0.93 to 1.25; clinically indicated 317/3590; 3‐day change 307/3733, moderate‐certainty evidence, downgraded once for serious risk of bias). The result was unaffected by whether the infusion was continuous or intermittent. Six trials provided thrombophlebitis rates by number of device days (32,709 device days). There is no clear difference between groups (RR 0.90, 95% CI 0.76 to 1.08; clinically indicated 248/17,251; 3‐day change 236/15,458; moderate‐certainty evidence, downgraded once for serious risk of bias). One trial (3283 participants), assessed all‐cause blood stream infection (BSI). We found no clear difference in the all‐cause BSI rate between the two groups (RR 0.47, 95% CI 0.15 to 1.53; clinically indicated: 4/1593 (0.02%); routine change 9/1690 (0.05%); moderate‐certainty evidence, downgraded one level for serious imprecision). Three trials (4244 participants), investigated costs; clinically indicated removal probably reduces device‐related costs by approximately AUD 7.00 compared with routine removal (MD −6.96, 95% CI −9.05 to −4.86; moderate‐certainty evidence, downgraded once for serious risk of bias). Secondary outcomes Six trials assessed infiltration (7123 participants). Routine replacement probably reduces infiltration of fluid into surrounding tissues compared with a clinically indicated change (RR 1.16 (95% CI 1.06 to 1.26; routine replacement 747/3638 (20.5%); clinically indicated 834/3485 (23.9%); moderate‐certainty evidence, downgraded once for serious risk of bias). Meta‐analysis of seven trials (7323 participants), found that rates of catheter failure due to blockage were probably lower in the routine‐replacement group compared to the clinically indicated group (RR 1.14, 95% CI 1.01 to 1.29; routine‐replacement 519/3733 (13.9%); clinically indicated 560/3590 (15.6%); moderate‐certainty evidence, downgraded once for serious risk of bias). Four studies (4606 participants), reported local infection rates. It is uncertain if there are differences between groups (RR 4.96, 95% CI 0.24 to 102.98; clinically indicated 2/2260 (0.09%); routine replacement 0/2346 (0.0%); very low‐certainty evidence, downgraded one level for serious risk of bias and two levels for very serious imprecision). One trial (3283 participants), found no clear difference in the incidence of mortality when clinically indicated removal was compared with routine removal (RR 1.06, 95% CI 0.27 to 4.23; low‐certainty evidence, downgraded two levels for very serious imprecision). One small trial (198 participants) reported no clear difference in device‐related pain between clinically indicated and routine removal groups (MD −0.60, 95% CI −1.44 to 0.24; low‐certainty evidence, downgraded one level for serious risk of bias and one level for serious imprecision). The pre‐planned outcomes 'number of catheter re‐sites per patient', and 'satisfaction' were not reported by any studies included in this review. Authors' conclusionsThere is moderate‐certainty evidence of no clear difference in rates of CRBSI, thrombophlebitis, all‐cause BSI, mortality and pain between clinically indicated or routine replacement of PIVC. We are uncertain if local infection is reduced or increased when catheters are changed when clinically indicated. There is moderate‐certainty evidence that infiltration and catheter blockage is probably lower when PIVC are changed routinely; and moderate‐certainty evidence that clinically indicated removal probably reduces device‐related costs. The addition of two new trials for this update found no further evidence to support changing catheters every 72 to 96 hours. Healthcare organisations may consider changing to a policy whereby catheters are changed only if there is a clinical indication to do so, for example, if there were signs of infection, blockage or infiltration. This would provide significant cost savings, spare patients the unnecessary pain of routine re‐sites in the absence of clinical indications and would reduce time spent by busy clinicians on this intervention. To minimise PIVC‐related complications, staff should inspect the insertion site at each shift change and remove the catheter if signs of inflammation, infiltration, occlusion, infection or blockage are present, or if the catheter is no longer needed for therapy. Plain language summaryReplacing a peripheral venous catheter when clinically indicated versus routine replacement Review question We reviewed the evidence about the effects of changing a catheter routinely (every three to four days) or changing the catheter only if there were signs or symptoms of a problem with the catheter remaining in place. Background Most hospital patients receive fluids or medications via a peripheral intravenous catheter at some time during their hospital stay. An intravenous catheter (also called an IV drip, an IV line or intravenous cannula) is a short, hollow tube placed in the vein to allow administration of medications, fluids or nutrients directly into the bloodstream. These catheters are often replaced every three to four days to try to prevent irritation of the vein or infection of the blood. However, replacing the catheter may cause discomfort to patients and is quite costly. This is the third update of a review first published in 2010. Study characteristics In April 2018 we searched for randomised controlled trials (RCTs) that compared changing catheters every 72 to 96 hours (routine change) with changing the catheter only if there were complications or therapy was complete. We measured catheter‐related blood stream infection, phlebitis and other problems associated with peripheral catheters, such as local infection and catheter blockage. We included two new studies for this update, bringing the total to nine studies with 7412 participants. Key results We found no clear difference in rates of catheter‐related blood stream infection, phlebitis (inflammation of the vein), blood stream infection from any cause, local infection, mortality or pain. We are uncertain if local infection is reduced or increased when catheters are changed when clinically indicated. Infiltration (fluid seeping into the tissue around the catheter) and catheter blockage (an inability to infuse fluids or medication through the catheter), are probably reduced when catheters are changed routinely. Cost is reduced when catheters are replaced when there was a clinical indication to do so. The pre‐planned outcomes 'number of catheter re‐sites per patient', and 'satisfaction' were not reported by any studies included in the review. Quality of the evidence The overall quality of the evidence was judged to be moderate for most outcomes, which leaves us uncertain of our findings. The uncertainty is largely due to outcomes, such as phlebitis, being assessed by people who were aware of the group allocation, which may or may not affect their decision about whether a problem is present or absent. Summary of findingsBackgroundAmong hospitalised patients, vascular access is the most common invasive procedure with 80% of hospital admissions involving an average of two vascular access devices per patient (Hadaway 2012). Peripheral intravenous (IV) access is associated with a pooled proportion for phlebitis of 36% (Marsh 2018a), and a pooled proportion catheter‐related blood stream infection (CRBSI) rate of less than 0.1% (Marsh 2018a). A number of current guidelines have been updated to reflect findings from previous versions of this systematic review (Webster 2015), recommending changing short peripheral intravenous catheters (PIVC) when there is a clinical indication to do so (Infusion Nurses Society 2011; Loveday 2014). However, the influential Centers for Disease Control (CDC) guidelines state that, "no recommendation is made regarding replacement of peripheral catheters in adults only when clinically indicated" (p. 15, O'Grady 2011). In practice most hospitals already exempt patients with poor veins from routine changes and, for children, CDC guidelines have always recommended that PIVC be replaced only when clinically indicated (O'Grady 2011). In recent years, there have been improvements in catheter design and composition, and more recent studies, including an earlier version of this review (Webster 2015), indicate that the recommendation may need to be revised. Based on level 1 evidence, the most recent Infusion Nursing Standards of Practice in the USA and the epic3 National Evidence Based Guidelines in the UK recommend that short PIVC should be replaced when clinically indicated, unless the patient is receiving parenteral nutrition peripherally (Infusion Nurses Society 2011; Loveday 2014). The projected five‐year savings from implementing clinically indicated PIVC removal policies is USD 300 million and 1 million health‐worker hours in the USA alone (Tuffaha 2014a; Tuffaha 2014b). Description of the conditionCatheter‐related blood stream infection (CRBSI), defined as the presence of bacteraemia originating from an intravenous (IV) catheter, is a rare but severe outcome of IV catheterisation (Gahlot 2014). The infection occurs when bacteria track along the catheter and enter the bloodstream. The bacterial source may be the patient's own skin or that of a healthcare provider; CRBSI has an attributable mortality rate of 12% to 25% (Maki 2006). Peripheral vein infusion thrombophlebitis (phlebitis) is characterised by pain, erythema (redness of the skin), swelling, and palpable thrombosis of the cannulated vein (Monreal 1999). Diagnosis remains controversial and a number of grading systems have been proposed, although with limited validation testing performed (Ray‐Barruel 2014). These include the Maddox scale (Maddox 1977), and the Baxter scale (Panadero 2002), which rank infusion thrombophlebitis according to the severity of clinical signs and symptoms. The scales are limited because not all symptoms may be present, or they may not always be present in the clusters described in the scales. Consequently, many investigators define peripheral vein infusion thrombophlebitis based on two or more of the following; pain, tenderness, warmth, erythema, swelling, and a palpable cord (Maki 1991; Monreal 1999). More recently, a new definition for phlebitis has been proposed, one based on a more objective assessment of the insertion site (Rickard 2012). Although the precise pathogenesis of thrombus formation remains unclear, it is thought to be related to inflammation of the vein wall. Studies have been unable to demonstrate a high correlation between phlebitis and catheter infection and Maki has suggested that phlebitis may primarily be a physical response (Maki 1991). This suggestion was supported by Catney and colleagues when investigating the aetiology of phlebitis; they found that drug irritation, size of catheter, and the person inserting the catheter were all predictors of phlebitis (Catney 2001). Utrasonographic imaging has demonstrated thrombus formation in two‐thirds of catheterised veins studied and it has been suggested that catheter design may be implicated (Everitt 1997). Thus, possible causes of phlebitis are mechanical irritation from the catheter and the properties of the infusate or IV‐administered medications, particularly flucloxacillin, which is associated with a two‐fold increase in phlebitis (Marsh 2018b). Description of the interventionThe intervention under consideration is replacing an PIVC only if there are clinical indications to do so. Clinical indications include blockage, pain, redness, infiltration, swelling, leakage, and phlebitis, as well as when therapy is completed. How the intervention might workEach time a catheter is inserted, the patient's skin integrity is breached and a potential portal for pathogens is provided. For example, a significant relationship was found between the number of times PIVC were inserted and phlebitis in a study of 568 IV sites (Uslusoy 2008). Consequently, it may be prudent to limit the frequency of PIVC replacements if there is no clinical reason to do so. There is some support for this approach from observational studies that have compared outcomes between catheters remaining in situ for varying periods. In an adequately powered observational study, which included participants from medical wards and intensive care units, the investigators were unable to demonstrate any increased risk of phlebitis beyond the second day (Bregenzer 1998). Similarly, in a retrospective study of 784 IV catheter starts, the rate of phlebitis on days one and two was 11.5%, dropping to 3.9% by day four (Homer 1998). The authors concluded that, “there appeared to be less risk in continuing therapy beyond the third day than re‐starting the therapy” (pp 304). Catney 2001 also failed to demonstrate any increase in phlebitis rates with the passage of time, with failure rates being less at 144 hours (1.9%) than at 72 hours (2.5%) (Catney 2001). Similarly, in a prospective investigation of 305 PIVC there were 10 cases of infusion phlebitis amongst patients who had their catheter in situ for fewer than 72 hours whereas none were reported in patients where the dwell time was longer (White 2001). In the same study, there were three cases of post‐infusion phlebitis; these all occurred amongst participants whose PIVC had been in place for fewer than 72 hours. Even among a high‐risk population of oncology and infectious diseases patients, phlebitis rates were no different when length of cannulation was dichotomised to three days or fewer and more than three days (Cornely 2002). Why it is important to do this reviewThese observational studies and previous versions of our Cochrane Review (Webster 2010; Webster 2013; Webster 2015), create uncertainty around the US Centers for Disease Control (CDC) guidelines relating to PIVC management, which states that clinically indicated replacement in adults is an "unresolved issue" (O'Grady 2011). The recommendation referenced an earlier version of this review (Webster 2010), which showed 'no difference' between the two approaches to PIVC replacement. As long as discrepancies exist between the CDC recommendations, often seen as the gold standard, and other international guidelines, updating this review with contemporary evidence is important. Particularly when 'choosing wisely' commentators find that "routine replacement should be considered a thing that we do for no reason" (Patel 2017). The review is also important because insertion of a PIVC may be painful, especially when placed in the hand or wrist, with an average score of 4.5 on a 10‐point pain scale (Tan 2016), so preventing unnecessary replacements may reduce a potentially traumatic experience for patients. Additionally, routine replacement has significant cost implications for the facility. Routine replacement costs approximately AUD 7 more per patient compared with clinically indicated replacement (Tuffaha 2014a). With an estimated two billion PIVC used globally each year (Rickard 2018), there is a clear need to provide direction for clinicians and administrators by systematically searching for and appraising relevant studies to add to the review. ObjectivesTo assess the effects of removing peripheral intravenous catheters when clinically indicated compared with removing and re‐siting the catheters routinely. MethodsCriteria for considering studies for this reviewTypes of studiesWe considered all randomised controlled trials (RCTs) comparing routine removal of PIVC with removal only when clinically indicated. Cross‐over trials were not eligible for inclusion. Types of participantsWe included any patient requiring a PIVC to be in situ for at least three days for the administration of intermittent or continuous therapy (this may include patients in hospitals, nursing homes, or in community settings). We excluded participants receiving parenteral fluids. Types of interventionsWe included short PIVC made from any type of material (for example metal, plastic); non‐coated or coated with any type of product (for example antibiotic, anticoagulant); or covered by any type of dressing (for example gauze, clear, occlusive). We included any duration of time before routine replacement versus clinically indicated replacement. We excluded midline catheters and long peripheral catheters. Types of outcome measuresPrimary outcomes
Secondary outcomes
Search methods for identification of studiesThere was no restriction on language. If foreign language studies had been found, we intended to seek initial translation of abstracts for the application of the inclusion and exclusion criteria. Where necessary, the methods, results, and discussion sections would have been translated for inclusion in the review. Electronic searchesThe Cochrane Vascular Information Specialist (CIS) conducted systematic searches of the following databases for RCTs without language, publication year or publication status restrictions:
The Information Specialist modelled search strategies for other databases on the search strategy designed for CENTRAL. Where appropriate, they were combined with adaptations of the highly sensitive search strategy designed by the Cochrane Collaboration for identifying RCTs and controlled clinical trials (as described in the Cochrane Handbook for Systematic Reviews of Interventions Chapter 6, Lefebvre 2011). Search strategies for major databases are provided in Appendix 1. The Information Specialist searched the following trials registries on 18 April 2018:
Searching other resourcesWe contacted researchers and manufacturers in order to obtain any unpublished data. Reference lists of potentially useful articles were also searched. We also searched the following clinical trials registries:
Data collection and analysisSelection of studiesTwo review authors independently reviewed titles and abstracts identified through the search process (JW, NM). We retrieved full reports of all potentially relevant trials for further assessment of eligibility based on the inclusion criteria. If we excluded any full texts, we recorded the reasons. We completed a PRISMA flow chart (Liberati 2009; Figure 1), to summarise the selection process. As the review authors were also the investigators on some of the included trials, we allocated assessment to a review author who was not an investigator (former author KN). We settled differences of opinion by consensus or referral to a third review author. There was no blinding of authorship. Data extraction and managementFollowing Cochrane Vascular recommendations, two review authors (two of JW, CR, or SO) independently extracted data to a pre‐tested data extraction form. We resolved disagreements by discussion and, where necessary, by a involving third review author. We contacted authors of published and unpublished trials for additional information. We extracted the following main sets of data from each included study:
The first review author (JW) entered the data into Review Manager 5, with another review author (NM) checking data entry accuracy (Review Manager 2014). Assessment of risk of bias in included studiesTwo review authors (two of JW, CR, SO, NM) independently assessed the included studies using the Cochrane Collaboration tool for assessing risk of bias (Higgins 2017). This tool addresses six specific domains, namely sequence generation, allocation concealment, blinding, incomplete outcome data, selective outcome reporting, and other issues (for example extreme baseline imbalance). We resolved any disagreements between review authors by consensus or referral to a third review author. We contacted the investigators of included trials to resolve any ambiguities. Measures of treatment effectFor individual trials, effect measures for categorical outcomes included risk ratio (RR) with its 95% confidence interval (CI). For statistically significant effects, we calculated the number needed to treat for an additional beneficial outcome (NNTB) or number needed to treat for an additional harmful outcome (NNTH). For continuous outcomes the effect measure we used was mean difference (MD) or, if the scale of measurement differed across trials, standardised mean difference (SMD), each with its 95% CI. For any meta‐analyses (see below), for categorical outcomes we calculated the typical estimates of RR with their 95% CI; and for continuous outcomes we calculated the mean difference (MD) or a summary estimate for standardised mean difference (SMD), each with its 95% CI. We analysed data using the Cochrane Collaboration's Review Manager 5 software (Review Manager 2014). 'Summary of findings' tablesTo assess the overall body of evidence, we developed 'Summary of findings' tables for the following outcomes, using GRADE approach.
We assessed the certainty of the body of evidence against five principle domains: 1) limitations in design and implementation; 2) indirectness of evidence or generalisability of findings; 3) inconsistency of results, for example unexplained heterogeneity and inconsistent findings; 4) imprecision of results where confidence intervals were wide; and 5) other potential biases, for example publication bias or high manufacturer involvement (Schünemann 2017). We downgraded the evidence from 'high certainty' by one level for serious risk of bias or by two for very serious risk of bias. Unit of analysis issuesUnit of analysis issues may arise in catheter trials when the participant is randomised but the number of outcomes are reported per catheter. We resolved this issue by using the participant as the unit of analysis if the number of catheters and number of participants were similar (assuming one catheter per individual). The more difficult challenge is where studies randomise at the participant level, use the allocated intervention on multiple catheters per participant, and then analyse outcomes per catheter. Such approaches should be treated as cluster trials. If a cluster trial had been correctly analysed, we planned to include effect estimates in any meta‐analysis using the generic inverse methods in Review Manager 5 (Review Manager 2014). Comparing longer and shorter PIVC dwell times on crude incidence of complications is also problematic; this does not take into account the cumulative daily risk inherent with peripheral intravenous device (IVD) use. There is clearly a ‘per day risk’ that is present, and grows with each day of intravascular treatment, regardless of how many IVDs are used over the period of therapy. This cannot be extrapolated to mean that restricting (removing) individual IVDs will reduce overall risk. That is, an IVD in situ for seven days has seven days of exposure to risk compared with an IVD in use for only three days, but if the patient requires therapy for seven days in total then using multiple catheters over the period may not reduce risk but merely divide the same risk between multiple catheters. Appropriate time comparisons need to be made using statistics such as Kaplan‐Meier analysis, logistic regression, or Cox proportional models. It is vital that the participant is used as the unit of measurement (denominator for comparison), not the IVD. If a patient requires therapy, for example for five days, they may have one catheter used for the entire time or alternately multiple IVDs used over the five days. If the multiple catheters are viewed independently they may appear to have lower risk per catheter but the total risk for the patient over the five days may be the same. We dealt with this by only including studies where data were available per participant rather than per catheter. Where data were not originally analysed in this format we contacted the investigators (for example Van Donk 2009), to get these data. For comparison, we also included an analysis of phlebitis per catheter days where this information was available. Where a cluster‐randomised trial had been included but incorrectly analysed, we planned to record the unit of analysis issue in our 'Risk of Bias' assessment. If possible, we planned to approximate the correct analyses based on guidance from the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011a). That is, we calculated the 'design effect' by using the formula 1+ (M‐1) ICC where M is the average size of each cluster, We did identify one cluster‐randomised trial, the results of which did not appear to have been adjusted (Xu 2017). For this trial, we were unable to identify an external intracluster correlation coefficient (ICC), so used an estimate of 0.02 and calculated the average cluster size to be 58.9. Dealing with missing dataIf any outcome data remained missing despite our attempts to obtain complete outcome data from trial authors, we assessed the risk of bias of the missing data and decided if the missing data were at 'low' or 'high' risk of bias according to our 'Risk of bias' criteria (Higgins 2017). If we considered data to be missing at random, we analysed the available information. If standard deviations were missing, we planned to impute them from other studies or, where possible, compute them from standard errors using the formula SD = SE X √‾N where these were available (Higgins 2011b). Assessment of heterogeneityWe explored clinical heterogeneity by examining potentially influential factors, for example, intervention dwell time, care setting, or participant characteristics. We assessed statistical heterogeneity using the Chi 2 test (considering P < 0.10 to represent significant heterogeneity), along with the I2 statistic (Higgins 2003), which examines the percentage of total variation across studies due to heterogeneity rather than to chance. We planned to explore potential causes of moderate to significant heterogeneity (I2 > 30%) and use a random‐effects approach to the analyses (Deeks 2017). Assessment of reporting biasesWe assessed reporting bias using guidelines in the Cochrane Handbook for Systematic Reviews of Interventions (Sterne 2017). Reporting bias occurs when reports of research results are affected by the type and direction of results. We assessed reporting bias in each study as part of our 'Risk of Bias' evaluation. If sufficient study data had been available for individual outcomes (> 10 trials), we would have developed funnel plots and inspected them for evidence of publication bias. Data synthesisWhere clinical and statistical heterogeneity was low, we pooled results of comparable trials using a fixed‐effect model, and reported the pooled estimate together with its 95% CI. Otherwise, we used a random‐effects model for our meta‐analytic approach. In cases where clinical heterogeneity between studies was similar but heterogeneity was high, we planned to meta‐analyse results and attempt to provide an explanation for the heterogeneity. We conducted a narrative review of eligible studies where statistical synthesis of data from more than one study was not possible or considered not appropriate. Subgroup analysis and investigation of heterogeneityWe planned to analyse potential sources of heterogeneity using the following subgroup analyses.
Sensitivity analysisWe planned to perform sensitivity analyses to explore the effect of the following criteria:
ResultsDescription of studiesResults of the searchSee Figure 1. For this update, we identified 4541 unique records through our electronic search. After reading titles and abstracts there were two additional citations which we considered potentially relevant (Chin 2018; Xu 2017). Chin 2018 was an abstract of an Australian trial in newborn infants with insufficient information in the report to consider inclusion. We contacted the author, asking for further study details but have had no response; we have placed a reference to the report in the Studies awaiting classification section of the review. We retrieved the full text of the second study and have included it in this update (Xu 2017). We have also included results from an unpublished study, which we were aware of through our network of intravascular device researchers (Vendramim 2018). We did not find any additional trials in our search of trials registries. Included studiesNine RCTs, involving a total of 7392 participants met the inclusion criteria (Barker 2004; Nishanth 2009; Rickard 2010; Rickard 2012; Van Donk 2009; Vendramim 2018; Webster 2007; Webster 2008; Xu 2017), see Characteristics of included studies for details. Individual trial sizes ranged between 42 and 3283 participants. Five trials were carried out in Australia (Rickard 2010; Rickard 2012; Van Donk 2009; Webster 2007; Webster 2008), and one each was carried out in Brazil (Vendramim 2018), China (Xu 2017), England (UK (Barker 2004)), and India (Nishanth 2009). Five of the trials were conducted in single‐centre, acute inpatient settings (Barker 2004; Nishanth 2009; Rickard 2010; Webster 2007; Webster 2008), two were multicentred trials in large tertiary hospitals ‐ one in Australia (Rickard 2012) and one in Brazil (Vendramim 2018); the Chinese trial was a cluster trial, which randomised 20 hospital wards (Xu 2017); and one trial was undertaken in a community setting (Van Donk 2009). In eight trials (Barker 2004; Nishanth 2009; Rickard 2010; Rickard 2012; Vendramim 2018; Webster 2007; Webster 2008; Xu 2017), patients were included if they were receiving either continuous infusions or intermittent infusions for medication therapy, whereas the catheters in the Van Donk 2009 trial were used for intermittent medication therapy only. In seven trials (Rickard 2010; Rickard 2012; Van Donk 2009; Vendramim 2018; Webster 2007; Webster 2008; Xu 2017), the comparison was between routine care (planned 72‐ to 96‐hour changes) and clinically indicated changes. Barker 2004 and Nishanth 2009 compared 48‐hour changes with removal for clinical indications such as pain, catheter dislodgement, or phlebitis. Xu 2017; Rickard 2010 and Rickard 2012 defined CRBSI by using the CDC definition: a positive blood culture from a peripheral vein; clinical signs of infection; no other apparent source for the bloodstream infection except the IV catheter (in situ within 48 hours of the bloodstream infection); and a colonised IV catheter tip with the same organism identified in the blood (O'Grady 2011). In the Webster 2007 and Webster 2008 trials CRBSI was based on the isolation of a phenotypically identical organism from a catheter segment and a blood culture. None of the other trials provided definitions of CRBSI. Seven of the trials used a standard definition of two or more of the following: pain, warmth, erythema, swelling, or a palpable cord to define phlebitis (Barker 2004; Rickard 2010; Rickard 2012; Vendramim 2018; Webster 2007; Webster 2008; Xu 2017). Barker 2004 and Nishanth 2009 further classified phlebitis as either mild, moderate, or severe, depending on the area of erythema (Barker 2004), or on the number of symptoms (Nishanth 2009). Van Donk 2009 included the same symptoms as other trials but scored them as either one or two depending on the severity. A score of two or more was classified as phlebitis, consequently a participant may have had only one symptom, for example pain, to receive a positive diagnosis. Nishanth 2009; Rickard 2010; Rickard 2012; Van Donk 2009; Vendramim 2018; Webster 2007; Webster 2008; and Xu 2017 reported power calculations but Barker 2004 did not. All of the studies had institutional ethical approval. Risk of bias in included studiesSee individual 'Risk of bias' tables and Figure 2; Figure 3. 'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies 'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study AllocationBlindingIt was not possible to blind either the participants or the healthcare providers in any of the trials but we did not believe that outcomes would be affected by this knowledge so we judged all trials to be at low risk of performance bias, except for Barker 2004 which we considered to be at high risk of bias because the investigator was involved in all stages of the study. Outcome assessmentThe chief investigator was directly involved in assessing outcomes in Barker 2004 and Nishanth 2009. In the Van Donk 2009; Vendramim 2018; Webster 2007 and Webster 2008 trials, nurses caring for the participant or a dedicated IV service nurse made the assessment. None of the nurses were blinded to the group allocation but nor were any of them associated with the trial. In Rickard 2010; Rickard 2012 and Xu 2017, a dedicated research nurse, who was also aware of the allocation, undertook outcome assessment. Because outcome assessment could not be blinded (except for CRBSI), we classified all trials as high risk of bias. Incomplete outcome dataBarker 2004 did not provide a flow chart, so the numbers screened and eligible were unclear, nor did they report any dropouts. There was also an imbalance in the number of participants reported by group in this trial, which may indicate either a failure in the randomisation process in such a small trial or incomplete reporting. They did not report the number of protocol violations by group, and we judged Barker 2004 to be at high risk of attrition bias. The remaining eight studies were at low risk of bias as there was complete reporting and all provided a flow of participants through each stage and used intention‐to‐treat analysis (Nishanth 2009; Rickard 2010; Rickard 2012; Van Donk 2009; Vendramim 2018; Webster 2007; Webster 2008; Xu 2017). Nishanth 2009 did not report any protocol violations in the trial. In the Van Donk 2009; Vendramim 2018; Webster 2007; Webster 2008; and Xu 2017 trials, between 7% and approximately one third of the participants had protocol violations. Primarily, violations were in the routine replacement groups, where catheters were not replaced within the specified time period, reflecting day to day clinical practice. Other potential sources of biasFive studies were at low risk of other bias (Rickard 2012; Van Donk 2009; Vendramim 2018; Webster 2007; Webster 2008). Barker 2004 used two definitions of phlebitis, one of which stated that two symptoms were necessary; yet it appears that they diagnosed erythema alone as phlebitis, with severity based on the area of inflammation; which leads to an assessment of high risk for other bias. The extreme results in Nishanth 2009, where 100% of participants in the clinically indicated group developed phlebitis compared with 9% in the two‐day change group, suggests that chance or other unknown bias affected results in this small trial, to which we also gave a high‐risk judgement. Two studies were at unclear risk of bias (Rickard 2010; Xu 2017). The Xu 2017 cluster‐randomised trial analysed by individual not cluster; and significantly more participants in the routine‐change group received IV antibiotics compared to the clinically indicated group in Rickard 2010. Effects of interventionsSee: Table 1 Summary of findings for the main comparisonEffects of clinically‐indicated replacement compared to routine change of peripheral intravenous catheters
Routine changes versus clinically indicated changesCatheter‐related bloodstream infection (Analysis 1.1)Seven trials (7323 participants) assessed catheter‐related bloodstream infection (CRBSI; Rickard 2010; Rickard 2012; Van Donk 2009; Vendramim 2018; Webster 2007; Webster 2008; Xu 2017). There were no reported CRBSIs in five of these trials (Rickard 2010; Van Donk 2009; Vendramim 2018; Webster 2007; Xu 2017). There is no clear difference in the incidence of CRBSI between the clinically indicated (1/3590) and routine‐change (2/3733) groups. The RR was 0.61 but the confidence intervals (CI) were wide, creating uncertainty around the estimate (95% CI 0.08 to 4.68; Figure 4; Analysis 1.1). We judged the evidence as low certainty, as we downgraded two levels for serious imprecision. Forest plot of comparison 1, clinically indicated versus routine change, outcome: 1.1 Catheter‐related bloodstream infection Analysis Comparison 1 Clinically‐indicated versus routine change, Outcome 1 Catheter‐related blood stream infection. Thrombophlebitis (Analysis 1.2 and Analysis 1.3)All of the included studies reported incidence of phlebitis; the initial analysis was based on 7412 participants. When results of all trials were combined, heterogeneity was 65%. Consequently, we conducted a sensitivity analysis and removed the two trials with fewer than 100 participants (combined total n = 89), both of which used a two‐day replacement schedule and reported extreme results (Barker 2004; Nishanth 2009). Removing the two trials eliminated the heterogeneity (I2 = 0). We combined data from the remaining seven studies, with 7323 participants (Rickard 2010; Rickard 2012; Van Donk 2009; Vendramim 2018; Webster 2007; Webster 2008; Xu 2017). There was no clear difference in this outcome, whether catheters were changed according to clinical indications or routinely (RR 1.07, 95% CI 0.93 to 1.25; clinically indicated 317/3590; 3‐day change 307/3733; moderate‐certainty evidence, downgraded once for serious risk of bias (no blinding of outcome assessment in any of the trials)). The result was unaffected by whether the infusion was continuous or intermittent (Analysis 1.2; Figure 5). Forest plot of comparison 1, clinically indicated versus routine change, outcome: 1.2 Phlebitis Analysis Comparison 1 Clinically‐indicated versus routine change, Outcome 2 Phlebitis. In the two trials using a two‐day replacement schedule compared with clinically indicated changes (Barker 2004; Nishanth 2009), heterogeneity was over 60% so we did not combine results. In the first of these two trials, Barker 2004 reported that 11/26 (42.3%) participants in the clinically indicated group developed phlebitis compared with 1/21 (4.8%) in the two‐day change group. Nishanth 2009 diagnosed all of the participants in the clinically indicated group (21/21; 100.0%) with phlebitis and 2/21 (9.5%) in the two‐day group. We judged the evidence from these two trials to be very low certainty, downgraded two levels for very serious risk of bias and two levels for very serious imprecision. Six of the trials provided phlebitis rates by number of device days (Rickard 2010; Rickard 2012; Van Donk 2009; Vendramim 2018; Webster 2007; Webster 2008), but again, there is no clear difference between groups for this outcome (RR 0.90, 95% CI 0.76 to 1.08; clinically indicated 248/17,251; 3‐day change 236/15,458; moderate‐certainty evidence, downgraded once for serious risk of bias (no blind outcome assessment in any of the trials); Analysis 1.3; Figure 6). Forest plot of comparison 1 clinically indicated versus routine change, outcome: 1.3 Phlebitis per device days Analysis Comparison 1 Clinically‐indicated versus routine change, Outcome 3 Phlebitis per device days. All‐cause bloodstream infection (Analysis 1.4)One trial assessed this outcome (Rickard 2012). We found no clear difference in the all‐cause bloodstream infection rate between the two groups (RR 0.47, 95% CI 0.15 to 1.53; clinically indicated: 4/1593 (0.02%); routine change 9/1690 (0.05%)). We judged the evidence as moderate certainty, downgraded one level for serious imprecision (Analysis 1.4). Analysis Comparison 1 Clinically‐indicated versus routine change, Outcome 4 All‐cause blood stream infection. Cost (Analysis 1.5)Three trials (4244 participants) measured this outcome (Rickard 2012; Webster 2007; Webster 2008). Device‐related costs were measured in Australian dollars (AUD). Clinically indicated removal probably reduces device‐related costs by approximately AUD 7.00 per participant compared with routine removal (MD −6.96, 95% CI −9.05 to −4.86; moderate‐certainty evidence, downgraded once for serious risk of bias (no blind outcome assessment in any of the trials); Analysis 1.5). Analysis Comparison 1 Clinically‐indicated versus routine change, Outcome 5 Cost. Infiltration (Analysis 1.6)A total of six trials assessed infiltration in 7123 participants (Rickard 2010; Rickard 2012; Vendramim 2018; Webster 2007; Webster 2008; Xu 2017). Routine replacement probably reduces infiltration of fluid into surrounding tissues (747/3638; 20.5%) compared with the clinically indicated group (834/3485; 23.9%). The RR was 1.16 (95% CI 1.06 to 1.26); moderate‐certainty evidence, downgraded once for serious risk of bias (no blinding of outcome assessment in any of the trials; Analysis 1.6). Analysis Comparison 1 Clinically‐indicated versus routine change, Outcome 6 Infiltration. Catheter occlusion/blockage (Analysis 1.7)We included seven of the nine trials, reporting on 7323 participants, in this analysis (Rickard 2010; Rickard 2012; Van Donk 2009; Vendramim 2018; Webster 2007; Webster 2008; Xu 2017). Rates of catheter failure due to blockage were probably lower in the routine‐replacement group compared to the clinically indicated group (RR 1.14, 95% CI 1.02 to 1.27; routine‐replacement group 519/3733 (13.9%); clinically indicated group 560/3590 (15.6%); Analysis 1.7). We judged the evidence as moderate certainty, as we downgraded once for serious risk of bias (no blinding of outcome assessment in any of the trials). Analysis Comparison 1 Clinically‐indicated versus routine change, Outcome 7 Catheter blockage. Local infection (Analysis 1.8)Among the four trials measuring local infection (Rickard 2010; Rickard 2012; Webster 2007; Webster 2008), it is uncertain if there are differences in local infection rates between groups (RR 4.96, 95% CI 0.24 to 102.98; clinically indicated 2/2260 (0.09%); routine replacement 0/2346 (0.0%); very‐low‐certainty evidence, downgraded one level for serious risk of bias (no blinding of outcome assessment in any of the trials) and two levels for very serious imprecision (Analysis 1.8)). Analysis Comparison 1 Clinically‐indicated versus routine change, Outcome 8 Local infection. Mortality (Analysis 1.9)One trial reported this outcome (Rickard 2012). In the clinically indicated group 4/1593 (0.25%) died compared with 4/1690 (0.24%) in the routine‐replacement group (RR 1.06, 95% CI 0.27 to 4.23). We judged the evidence as low certainty, downgraded two levels for very serious imprecision (Analysis 1.9). Analysis Comparison 1 Clinically‐indicated versus routine change, Outcome 9 Mortality. Pain during infusion (Analysis 1.10)Vendramim 2018 (198 participants), measured pain on an 11‐point scale (0 to 10), where higher scores represented higher levels of pain. There was no clear difference in device‐related pain between clinically indicated and routine‐removal groups. The mean pain score in the clinically indicated group was 4.6 (SD 3.0), compared with 5.2 (SD 3.0), in the routine replacement group (MD −0.60, 95% CI −1.44 to 0.24; low‐certainty evidence, downgraded one level for serious risk of bias (no blinding of outcome assessment in any of the trials) and one‐level for serious imprecision; Analysis 1.10). Analysis Comparison 1 Clinically‐indicated versus routine change, Outcome 10 Pain during infusion. The pre‐planned outcomes 'number of catheter re‐sites per patient', and 'satisfaction' were not reported by studies included in the review. Subgroup and sensitivity analysisWe planned to conduct subgroup analyses on 1) Type of randomisation (truly randomised versus not reported); 2) Concealment of allocation (adequate versus not reported) and; 3) Statement of withdrawals and losses to follow‐up in each group (stated versus not stated). However, there were too few studies in these subgroups to make any meaningful comparisons. Similarly, blinding was not possible in any of the studies. We did not conduct any of our pre‐planned sensitivity analyses (except size of studies for the outcome 'phlebitis'), for similar reasons. DiscussionSummary of main resultsThis systematic review analysed catheter‐related bloodstream infection (CRBSI), phlebitis, other reasons for catheter failure, and cost with the intention of comparing routine catheter changes (at between two and four days) with replacing the catheter only if clinical signs warranting removal or replacement were apparent. This update, which added a further two trials, confirms findings from the previous version of this review (Webster 2015). The primary outcomes suggest that patients are not adversely affected if the catheter is changed based on clinical indications rather than routinely. The rate of catheter‐related bloodstream infection was similar in both groups, between 0.03% and 0.05%, and comparable to that previously reported in prospective studies (Maki 2006). Because the incidence of peripheral intravenous (IV) CRBSI is very low, mounting a trial with sufficient power to show differences in CRBSI between catheters removed routinely or by clinical indication would be prohibitive. There is no clear difference in the phlebitis rate between groups whether rates are reported by the incidence per participant or by 1000 device days, which is a more clinically useful measure. Most cases of phlebitis are mild in nature, requiring no treatment or only removal of the catheter. There was no indication in our review that phlebitis was a precursor to bloodstream infection. Catheter failure due to blockage was more frequent in the clinically indicated group. This could be expected; all catheters will fail eventually and will need to be replaced if treatment is ongoing. The outcome is not clinically meaningful, it is simply an indicator of the longer dwell times in the clinically indicated group. Since the ‘treatment’ for a blocked catheter is replacement of the catheter, it would not be of any benefit to the patient to replace the catheter earlier since it would not reduce the need for replacement, and would instead increase the chance of re‐cannulation. Many catheters do not fail over the course of IV treatment, even with extended dwell times. Cost was less, around AUD 7.00 per participant, in the clinically indicated group. This result was based on three studies and results were consistent and intuitively logical (fewer catheters, less clinician time and equipment). Although, this is a seemingly small amount, it corresponds to approximately 11% of catheter‐related expenditure, which may represent a considerable saving to organisations with high use of peripheral intravenous catheters (PIVC). Overall completeness and applicability of evidenceTrials included in this systematic review directly addressed the review question and we were able to conduct a number of meta‐analyses. Apart from Barker 2004 and Nishanth 2009, results from the other seven trials were quite similar, providing useful external validity. For example, participants were representative of those usually managed in healthcare, including patients in both acute and community settings. Additionally, measured outcomes were those important to clinicians and patients. It has been suggested that insertion and management by an IV team may explain the inefficacy of routine replacement to prevent complications (Maki 2008), yet we saw no effect in trials that had significant numbers inserted by an IV team (Webster 2007; Webster 2008), or trials where insertion was by the general medical and nursing staff (Rickard 2010; Rickard 2012), and none of the trials involved research nurses or IV teams providing post‐insertion care of catheters. In all of the trials, except for Barker 2004 and Nishanth 2009, standard guidelines were followed for the control group; that is, catheters were changed at between 72 and 96 hours, reflecting usual care. Barker 2004 and Nishanth 2009 changed catheters every 48 hours. Only Rickard 2012 was powered to report on phlebitis alone, and some of the trials were very small. For example, the studies that showed statistically lower phlebitis rates in the clinically indicated group (Barker 2004; Nishanth 2009), involved just 47 and 42 participants respectively and showed differences between the control and intervention groups that were quite dissimilar to all of the other studies. Consequently, results of these two trials should be interpreted with caution, particularly results from Nishanth 2009, where all participants in the clinically indicated group developed phlebitis compared with none in the two‐day change group. It seems unlikely that these results would have occurred by chance but correspondence with trial authors shed no further light on these extreme results. There are no other published papers showing phlebitis rates of 100%. Five of the nine included trials were conducted in Australia; this imbalance is difficult to understand but the two additional studies, one from China (Xu 2017), and one from Brazil (Vendramim 2018), provide added diversity to the evidence and increase external validity. It would be useful to see similar studies from other healthcare settings to test the robustness of results from this review. Only Vendramim 2018 assessed levels of pain, and none of the trials measured device‐related satisfaction or number of catheter re‐sites per participant. These outcomes would be a useful addition to any future trial. Quality of the evidenceSee Table 1 Overall we found the quality of evidence for most outcomes to be of moderate to low quality, primarily due to risk of bias (particularly non‐blinding of the outcome assessor), and imprecision. Imprecision was due in some cases, such as 'pain', to few participants but in other cases, such as mortality, to few events. Limitations in study design and implementationWe assessed risk of bias according to six components: sequence generation, allocation concealment, blinding, selective outcome reporting, incomplete follow‐up, and other potential biases. All of the studies (except Nishanth 2009), avoided selection bias and ensured allocation concealment. We rated the evidence for methodological quality of most of the outcomes as moderate. It was not possible to blind the intervention in any of the trials because it was necessary to identify the catheter as either 'routine change' or 'clinically indicated', to prevent inadvertent routine replacement of catheters in the intervention group. It is unclear if this had any bearing on outcomes but we decided to downgrade one level for all outcomes except CRBSI, where a blinded microbiologist diagnosed the condition. However, as one trial author noted, it is routine practice to record reasons for removal of an IV catheter in the medical record, and it is unlikely that such entries would be falsified based on group allocation (Webster 2008). In Barker 2004 and Nishanth 2009, the investigator was directly involved in diagnosing phlebitis; in all of the other studies either medical staff, ward nurses, IV therapy staff, or research nurses evaluated the outcomes. Indirectness of evidenceAll of the trials compared routine changes with clinically indicated changes. However, seven trials used a three to four‐day change schedule and two trials changed catheters every two days. Consequently, three to four‐day results may provide indirect evidence for two‐day changes, conversely two‐day changes provide indirect evidence for a three to four‐day change schedule. Additionally, only Nishanth 2009 included participants who were from a low‐income country and who were, "usually asthenic, many underhydrated/dehydrated on admission" (personal correspondence), so the evidence may be regarded as indirect for these types of patients. Unexplained heterogeneity or inconsistency of resultsWhen we combined results of studies that investigated the effect of different catheter replacement schedules on phlebitis, the heterogeneity was high. This was probably due to the different schedules for the routine catheter changes or population differences, or both. Small sample sizes may also have contributed to the extreme results, which caused the heterogeneity. We tested these assumptions by performing a sensitivity analysis, removing two of the nine studies. Results of all trials are presented in the review text and of seven trials in the 'Summary of findings' table (Table 1). Imprecision of resultsConfidence intervals were wide in the pooled outcomes of CRBSI, all‐cause blood stream infection, local infection, mortality and pain, indicating a high level of uncertainty around the effect size. Further research is therefore very likely to have an important impact on the confidence in the estimate of effect for these outcomes. Publication biasWe feel confident that our comprehensive electronic searches, handsearching, and searches of large clinical trials databases, identified all existing, published, randomised controlled trials addressing the review question. We also have an established international network of researchers in the field of vascular access, who alert us to new trials. We would have developed a funnel plot to detect reporting bias, if we had included more than 10 studies in the review. Potential biases in the review processAlthough the review authors were investigators in one or more of the included trials, we followed clearly described procedures to prevent potential biases in the review process. We conducted a careful literature search and the methods we used were transparent and reproducible. None of the review authors has any conflict of interests. Agreements and disagreements with other studies or reviewsOur results concur with several, prospective observational studies, which found no additional risk in extending intravenous device (IVD) dwell times (Abolfotouh 2014; Catney 2001; White 2001). In addition, two implementation studies, which changed their policies to replacing PIVCs only if clinical indications were present, showed no increase in rates of PIVC‐related infection (Bolton 2015; De Vries 2016). In addition, Bolton 2015 reported a significant cost saving with a 25% stock reduction. Similarly, in the De Vries 2016 study, peripheral line start kits were reduced by 48% in the year following the policy change. Two recently published reviews, assessing the effect of changing PIVCs only where a clinical indication exists also concurred with our results (Morrison 2015; Patel 2017). Importantly, international and other guidelines have been changed to reflect the results of this review (Gorski 2016; Ho 2011; Loveday 2014). One of our outcomes was catheter‐related blood stream infection (CRBSI). We included seven RCTs (over 7000 participants), and found no evidence that dwell time had any effect on this outcome. In contrast, in another systematic review, Mermel 2017 suggested that longer dwell times resulted in higher CRBSI rates. The reason for the discrepancy between the two reviews is the inclusion criteria. We included only RCTs whereas Mermel 2017 included incidence studies, quality improvement studies, quasi‐experimental designs and a number of RCTs where difference in dwell time was not the focus of the study. When participants are not randomised, or not randomised for the purpose of assessing the effect of dwell time on catheter‐related outcomes, a potential for bias exists. For example, the sickest participants, those most likely to develop a CRBSI, are also those who would be expected to have their catheters in place for longer periods. Randomisation ensures risk factors that may affect the outcome, are equally distributed between groups. Authors' conclusionsImplications for practiceThis review update found moderate to low‐certainty evidence of no clear difference in rates of catheter‐related bloodstream infection (CRBSI), thrombophlebitis, all‐cause bloodstream infection, mortality or pain between clinically indicated or routine replacement of peripheral intravenous catheters. We are uncertain if local infection is reduced or increased when catheters are changed when clinically indicated. There is moderate‐certainty evidence that infiltration and catheter blockage is probably lower when PIVC are changed routinely; and moderate‐certainty evidence that clinically indicated removal probably reduces device‐related costs. The consistency in these results, which include two very large multisite studies, indicate that healthcare organisations should consider changing to a policy whereby catheters are changed only if there is a clinical indication to do so, for example, if there were signs of infection, blockage or infiltration. This would provide significant cost savings and would also be welcomed by patients, who would be spared the unnecessary pain of routine re‐sites in the absence of clinical indications. Time spent by busy clinical staff on this intervention would also be reduced. To minimise peripheral catheter‐related complications, the insertion site should be inspected at each shift change and the catheter removed if signs of inflammation, infiltration, or blockage are present, or as soon as therapy is completed. Implications for researchBased on results from the meta‐analyses in this review, a sample size of greater than 25,000 participants would be required to show clear differences between groups for the most important outcomes in this review, that is CRBSI and phlebitis. Consequently, it is unlikely that such a trial is warranted, given the low event rate for CRBSI and the very high number needed to treat (almost 1700) for one patient to avoid phlebitis. What's new
HistoryProtocol first published: Issue 2, 2009
AcknowledgementsWe acknowledge the input of Dr Karen New in previous versions of the review. We are grateful to Marlene Stewart, Cochrane Vascular Managing Editor, for her support and speedy responses, and to the editors Mr Paul Tisi and Dr Jackie Price for their useful comments. AppendicesAppendix 1. Search strategies
NotesNew search for studies and content updated (no change to conclusions) Data and analysesComparison 1Clinically‐indicated versus routine change
Characteristics of studiesCharacteristics of included studies [ordered by study ID]
Characteristics of excluded studies [ordered by study ID]
Characteristics of studies awaiting assessment [ordered by study ID]
Differences between protocol and review2018 update
Previous updates We changed the primary outcome to catheter‐related bloodstream infection; and added all‐cause bloodstream infection as a separate primary outcome. This was to more closely differentiate between the two outcomes. The methodological quality assessment of the included studies was updated to the Cochrane Collaboration tool for assessing risk of bias (Higgins 2017). Contributions of authorsJW: conceived the idea for the review, wrote the protocol, selected trials for inclusion, assessed methodological quality of trials and extracted data, entered the data, developed the analysis plan for the update and drafted the review update,
guarantor of the review. Sources of supportInternal sources
External sources
Declarations of interestJW: none known Some of the review authors were also the investigators on several of the included trials, To eliminate any potential for a conflict of interest, assessment was allocated to a review author who was not an investigator. ReferencesReferences to studies included in this reviewBarker 2004 {published and unpublished data}
Nishanth 2009 {published data only}
Rickard 2010 {published and unpublished data}
Rickard 2012 {published and unpublished data}
Van Donk 2009 {published and unpublished data}
Vendramim 2018 {unpublished data only}
Webster 2007 {published and unpublished data}
Webster 2008 {published and unpublished data}
Xu 2017 {published data only}
References to studies excluded from this reviewArnold 1977 {published data only}
Cobb 1992 {published data only}
Eyer 1990 {published data only}
Haddad 2006 {published data only}
Kerin 1991 {published data only}
May 1996 {published data only}
Nakae 2010 {published data only}
Panadero 2002 {published data only}
Rijnders 2004 {published data only}
References to studies awaiting assessmentChin 2018 {published data only}
Additional referencesAbolfotouh 2014
Bolton 2015
Bregenzer 1998
Catney 2001
Cornely 2002
De Vries 2016
Deeks 2017
Everitt 1997
Gahlot 2014
Gorski 2016
Hadaway 2012
Higgins 2003
Higgins 2011a
Higgins 2011b
Higgins 2017
Ho 2011
Homer 1998
Infusion Nurses Society 2011
Lefebvre 2011
Liberati 2009
Loveday 2014
Maddox 1977
Maki 1991
Maki 2006
Maki 2008
Marsh 2018a
Marsh 2018b
Mermel 2017
Monreal 1999
Morrison 2015
O'Grady 2011
Patel 2017
Ray‐Barruel 2014
Review Manager 2014 [Computer program]
Rickard 2018
Schünemann 2017
Sterne 2017
Tan 2016
Tuffaha 2014a
Tuffaha 2014b
Uslusoy 2008
White 2001
References to other published versions of this reviewWebster 2009
Webster 2010
Webster 2013
Webster 2015
Articles from The Cochrane Database of Systematic Reviews are provided here courtesy of Wiley How often should a midline dressing be changed?Clean the skin and change the dressing 3 times a week for gauze and tape dressing (such as Monday, Wednesday and Friday). Clean the skin and change the dressing every 7 days if you have a clear dressing. Change the dressing as soon as possible if it becomes dirty, wet or loose. Never use scissors near the midline.
How often should central lines be changed?A daily inspection should ensure that the line is properly in place, free from infection, and in working order. Dressing changes for central lines should occur every 5 to 7 days with a transparent dressing or every two days with a gauze dressing.
How often should an IV line be changed CDC?Replace intravenous tubing, including add-on devices, no more frequently than at 72-hour intervals unless clinically indicated. Replace tubing used to administer blood, blood products, or lipid emulsions within 24 hours of initiating the infusion.
What should the nurse document after inserting a venous catheter?The documentation should include the IV site (vein specific), date, time, and the number of attempts, gauge and length, and brand of catheter. Document any problems with insertion. Document the patient response to the insertion procedure.
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