Original Article
A Controlled Trial of Scheduled Replacement of Central Venous and Pulmonary-Artery Catheters
N Engl J Med 1992; 327:1062-1068October 8, 1992
- Abstract
- Abstract
Background.
The incidence of infection increases with the prolonged use of central vascular catheters, but it is unclear whether changing catheters every three days, as some recommend, will reduce the rate of infection. It is also unclear whether it is safer to change a catheter over a guide wire or insert it at a new site.
Methods.
We conducted a controlled trial in adult patients in intensive care units who required central venous or pulmonary-artery catheters for more than three days. Patients were assigned randomly to undergo one of four methods of catheter exchange: replacement every three days either by insertion at a new site (group 1) or by exchange over a guide wire (group 2), or replacement when clinically indicated either by insertion at a new site (group 3) or by exchange over a guide wire (group 4).
Results.
Of the 160 patients, 5 percent had catheter-related bloodstream infections, 16 percent had catheters that became colonized, and 9 percent had major mechanical complications. The incidence rates (per 1000 days of catheter use) of bloodstream infection were 3 in group 1, 6 in group 2, 2 in group 3, and 3 in group 4; the incidence rates of mechanical complications were 14, 4, 8, and 3, respectively. Patients randomly assigned to guide-wire—assisted exchange were more likely to have bloodstream infection after the first three days of catheterization (6 percent vs. 0, P = 0.06). Insertions at new sites were associated with more mechanical complications (5 percent vs. 1 percent, P = 0.005).
Conclusions.
Routine replacement of central vascular catheters every three days does not prevent infection. Exchanging catheters with the use of a guide wire increases the risk of bloodstream infection, but replacement involving insertion of catheters at new sites increases the risk of mechanical complications. (N Engl J Med 1992;327: 1062–8.)
Media in This Article
Figure 1
The Temporal Sequence of Catheter Changes and the Occurrence of Catheter-Related Bloodstream Infections in Eight Patients in the Four Study Groups.Table 1
Patients' Characteristics, According to Their Group Assignment at the Time of Randomization.*Article Activity
- Article
CENTRAL vascular catheters are widely used in critically ill patients. They permit hemodynamic monitoring and allow access for the administration of fluids, blood products, medications, and total parenteral nutrition, but they also pose a hazard of serious infectious and mechanical complications. Bloodstream infection is a serious catheter-related complication with an estimated case fatality rate of 10 to 20 percent.1 Single-lumen catheters maintained for parenteral nutrition by strict aseptic techniques have a low cumulative incidence of bacteremia, averaging 6 percent, and are not regarded as requiring routine replacement.2 3 4 5 6 7 8 Multilumen and pulmonary-artery catheters used for hemodynamic monitoring in critically ill patients may pose higher risks of infection.9 10 11 12 13 14 15 16 Several observational studies have linked higher infection rates to the use of a catheter for more than three to four days,9 10 11 12 13 14 , 17 18 19 20 21 leading some investigators to recommend scheduled replacement to reduce this risk.17 , 22 23 24 25 The effectiveness of this approach, however, has not been clearly established.
Major mechanical complications occur after about 4 percent of initial insertions and include pneumothorax, hemothorax, thrombophlebitis, bleeding, and cardiac arrhythmias.26 27 28 29 30 The use of guide-wire assistance for catheter exchanges is common in modern intensive care units,31 32 33 34 35 and this approach has a lower risk of mechanical complications than exchanges involving punctures at new sites.30 , 36 37 38 39 40 The safety of guide-wire—assisted exchange with respect to infection has been questioned, however. Studies comparing infection rates with the two techniques of catheter replacement have yielded conflicting results.9 , 36 37 38 39 40 41 42 43 44 We report the results of a randomized trial that evaluated the efficacy of scheduled catheter replacement every three days by the use of either a new puncture site or guide-wire—assisted exchange. We monitored the risk of subsequent infectious complications and the safety of these replacements with respect to mechanical complications.
Methods
Study Population
The University of Virginia Hospital is a 695-bed teaching hospital located in Charlottesville. From October 1988 to January 1990, adult patients in the intensive care unit who had triple-lumen catheters or pulmonary-artery catheters inserted through the internal jugular or subclavian veins for more than 72 hours were eligible to participate. Patients were excluded if they were younger than 18 years of age, had coagulopathy (prothrombin-time ratio [International Normalized Ratio], >1.85) or thrombocytopenia (platelet count, <50,000 per cubic millimeter [<50×109 per liter]), had catheters that had not been inserted aseptically, or had catheters that had been previously placed by guide-wire—assisted exchange. Consent was obtained from all patients, and the study was approved by the University of Virginia Human Investigation Committee.
Randomization
Patients were randomly assigned in stratified fashion within medical and surgical populations, according to a factorial design, to four groups: group 1, in which catheters were replaced every three days with the use of a new puncture site; group 2, in which catheters were replaced every three days with the use of guide-wire—assisted exchange; group 3, in which catheters were replaced only as clinically indicated with the use of a new puncture site; and group 4, in which catheters were replaced only as clinically indicated with the use of guide-wire—assisted exchange.
Catheter Exchange
Decisions to replace a catheter because of clinical indications such as unexplained fever or catheter malfunction in the patients in groups 3 and 4 were made by the primary physicians, as were decisions regarding catheter replacement in groups 2 and 4. Catheters with exit-site infections were removed immediately, and a new puncture site was selected if central venous access was still required. The reasons for the replacement of catheters and deviations from the catheter-exchange protocol were recorded for each group.
Data Collection
Underlying illnesses, antibiotic therapy, distant foci of infection, and other vascular devices present at the time of catheter insertion were recorded. An APACHE II45 score was calculated as an index of illness severity (this scoring system is a 71-point scale in which a score of 0 indicates the least severe illness and a score of 71 the most severe illness). Risk factors for infection were reviewed daily, including pressure monitoring, parenteral nutrition, antibiotic therapy, endotracheal intubation, neutropenia, and distant foci of infection as previously defined.46 The type of catheter used, use of an introducer sheath, operator's level of training, dates and times of insertion and removal, and mechanical and infectious complications were recorded.
Protocol for Catheter Insertion and Removal and Dressings
Resident physicians inserted and exchanged the catheters after washing their hands and donning masks, sterile gowns, and gloves. The puncture site was prepared with 10 percent povidone—iodine solution, and surrounding areas were covered with sterile drapes. Povidone—iodine ointment was applied to the site, and an occlusive cotton-gauze dressing was placed. Chest films were obtained after insertions or exchanges to ensure that the catheters were properly positioned and to diagnose mechanical complications. We used either 7-French, 30-cm, triple-lumen polyurethane central venous catheters or 7.5-French, 110-cm polyvinylchloride pulmonary-artery catheters with an 8-French introducer sheath. The preparation for guide-wire—assisted exchanges was similar, and 45-cm, J-tip stainless-steel guide wires with a diameter of 0.9 mm were used. The catheter-insertion sites were inspected and dressings were changed every 48 hours.
After the catheter was removed, the distal 5 cm of the tip was clipped off and put into one culture-swab container (Culturette; Marion Laboratories, Kansas City, Mo.) and the 5-cm subcutaneous segment was put into another container. If an introducer sheath was used, the sheath was considered the subcutaneous segment.
Microbiologic Analysis
Semiquantitative catheter cultures were performed with trypticase soy agar containing 5 percent sheep's blood, according to the method of Maki et al.47 Culture plates were incubated aerobically at 37°C, and colony counts performed at 24, 48, and 72 hours. The research-team microbiologists who examined the cultures were unaware of the patient's study-group assignment. Blood cultures were obtained by primary physicians if there were signs of fever or other indications of sepsis and processed by the Clinical Microbiology Laboratory according to standard methods.
Definition of Outcome Measures
The cumulative incidence was defined as the number of events divided by the number of patients or by the number of catheters. The incidence rate was defined as the number of events divided by the number of days the patient was at risk because of the presence of a catheter.
Catheter colonization was defined as growth of 15 or more colony-forming units of an organism on semiquantitative culture of the tip or subcutaneous segment.47 A catheter-related bloodstream infection was defined as isolation of the same organism from the blood and one or both catheter segments (≥15 colony-forming units), with no other identified source. Local infection at the site of catheter insertion was considered to be present if there was erythema with induration or tenderness at the site or pus.
Mechanical complications included the following: pneumothorax documented by chest radiography, arrhythmia temporally associated with catheter placement and requiring intervention, bleeding requiring transfusion, and clinically diagnosed central venous thrombosis.
Statistical Analysis
The frequency of categorical variables was assessed with a chi-square or Fisher's exact test. Mean values of quantitative variables were compared with analysis of variance and Student's t-test. The Wilcoxon rank-sum test was used for nonparametric testing of quantitative variables that were not normally distributed. All statistical analyses were conducted with SAS software.48 Calculations of the sample size showed that a total of 500 catheters would yield an 88 percent power to detect a 10 percent absolute difference (5 percent vs. 15 percent) in the rate per catheter of catheter-related complications among the patients randomly assigned to scheduled exchanges as compared with those assigned to clinically indicated exchanges.49
Results
Patients' Characteristics
Most patients in the study units did not require a catheter for more than 72 hours and therefore were not eligible for the study. A total of 90 patients who required a catheter for three or more days were also excluded. Fifty-eight patients were excluded before randomization, for the following reasons: coagulopathy (31 patients); thrombocytopenia (5 patients); the need for anticoagulation (4 patients); perceived danger from repeated puncture at new sites because of the presence of bullous chronic obstructive pulmonary disease (3 patients), a neck flap (1 patient), or clavicular fractures (1 patient); the patient's refusal to participate (8 patients); or the physician's refusal to allow a patient to participate (5 patients). Thirty-two patients were excluded after randomization, for the following reasons: their catheters were not changed (14 patients in group 1 and 1 in group 2), their catheters were lost (5 patients in group 3 and 3 in group 4), or the aseptic technique was compromised (9 patients). The groups of patients who did undergo randomization were comparable with respect to age, sex, mean APACHE II scores, the presence of underlying illnesses, and infection risk factors (Table 1Table 1
Patients' Characteristics, According to Their Group Assignment at the Time of Randomization.*).Characteristics of the Catheters
The results regarding a total of 523 catheters in 160 patients could be evaluated. Table 2Table 2
Characteristics of the Catheters, According to Study Group. lists the types of catheters used and their characteristics.First-year and second-year residents performed most of the catheter exchanges. Primary physicians decided where the catheters should be inserted. The right subclavian vein was the most frequently used site, followed by the left subclavian vein in all four groups. Patients whose catheters were changed every three days were significantly more likely than patients whose catheters were changed less frequently to require catheterization of an internal jugular vein as well. Reasons for catheter removal and the mean durations of catheterization are listed in Table 2.
Infectious Complications
Catheter-related bloodstream infection occurred in 2 percent of the catheters used in the study and involved 5 percent of the patients (Table 3Table 3
Types of Infectious and Mechanical Complications of Catheterization, According to the Number of Catheters Used and the Number of Patients Assigned to Each Group.*); the rates of infection per catheter inserted ranged from 1 percent in group 1 to 2 percent in group 4, and the rates of infection per patient studied ranged from 2 percent in group 3 to 10 percent in group 2 (P = 0.39). Five of the eight catheter-related bloodstream infections (63 percent) occurred in groups 1 and 2, in which the catheter was changed every three days, and one of the three catheter-related bloodstream infections in groups 3 and 4, in which the catheter was changed only when clinically indicated, occurred within three days of the placement of the first catheter. Thus, six of the eight bloodstream infections (75 percent) occurred within 72 hours of the initial catheter insertion or the replacement of a catheter (Fig. 1Figure 1The Temporal Sequence of Catheter Changes and the Occurrence of Catheter-Related Bloodstream Infections in Eight Patients in the Four Study Groups.). All five of the catheter-related bloodstream infections that occurred more than 72 hours after the initial catheter insertion were in patients in groups 2 and 4, who had guide-wire—assisted exchanges (5 of 84 patients, as compared with none of 76 patients in groups 1 and 3; 6 percent vs. 0 percent; P = 0.06); four of these five occurred after at least one guide-wire—assisted exchange.The incidence rate of catheter-related bloodstream infections per 1000 days of catheter use did not show a trend favoring scheduled replacement (Table 4Table 4
Incidence Rates of Infectious and Mechanical Complications, According to the Method of Catheter Replacement.*). The incidence rate of bloodstream infections during the first 3 days of catheterization in this trial was 6 per 1000 days of catheter use as compared with 2 per 1000 days of catheter use after the first 3 days of catheterization. The incidence rate of catheter-related bloodstream infections after the first 3 days was higher in the two scheduled-replacement groups (4 per 1000 days of catheter use) than in the other two groups (2 per 1000 days of catheter use).Seven of the eight catheters associated with bloodstream infections had 100 or more colony-forming units on semiquantitative culture of either the tip or subcutaneous segment. No infections were associated with a semiquantitative culture of fewer than 80 colony-forming units on a catheter segment. Five infections involved triple-lumen catheters, and three were related to pulmonary-artery catheters. Infections at the site of catheter insertion were infrequent in all four groups.
Colonization occurred in 5 percent of the catheters and in 16 percent of patients overall. There were no statistically significant differences in the rates of colonization among the four study groups. The frequencies of catheter colonization by various microbial species are given in Table 5Table 5
Microorganisms Colonizing Central Venous and Pulmonary-Artery Catheters, According to Study Group.. One patient in group 2 had colonization of Staphylococcus epidermidis in a catheter, which resulted in colonization of the next catheter inserted through the same site; in the analysis this patient was considered to have had only one instance of catheter colonization. Four other patients in groups 2 and 4 who had guide-wire-assisted catheter exchange had positive cultures of one catheter but not of the replacement catheter.Mechanical Complications
Fourteen major mechanical complications occurred during the study (Tables 3 and 4). The overall rates of mechanical complications per catheter inserted (3 percent) and per patient treated (9 percent) were higher than the rates of bloodstream infection. Sixty-four percent of the mechanical complications occurred among the patients who had new puncture sites with each exchange (groups 1 and 3), and two of the five mechanical complications in the groups who had guide-wire—assisted catheter exchange (groups 2 and 4) occurred during insertions at new puncture sites (20 patients in group 2 and 13 in group 4 had exchanges involving new-site punctures, and 7 patients in group 1 and 8 in group 3 had guide-wire—assisted exchanges). Thus, 11 of the 14 mechanical complications (79 percent) were associated with a new puncture site, whereas only 3 occurred during a guide-wire—assisted exchange (11 of 221 exchanges involving new puncture sites [5 percent] vs. 3 of 302 [1 percent]; P = 0.005). All patients with pneumothoraxes except one in group 2 required the insertion of a chest tube. Subclavian-vein thrombosis occurred only in patients who had new puncture sites with each exchange (groups 1 and 3). One patient in group 1 required a transfusion (three units of blood) because of bleeding.
Mortality
Twenty-seven patients (17 percent) died during the study. The mortality rate did not differ significantly among the four groups, ranging from 11 percent in group 1 to 20 percent in group 2. No patient was believed to have died of a catheter-related complication.
Discussion
A decade ago the Centers for Disease Control stated in its Guidelines for Prevention of Intravascular Infections that "the proper frequency for changing [central venous] cannulas that are used for pressure monitoring . . . is not known."50 Until recently, no randomized trial had tested the hypothesis that the scheduled replacement of catheters with either guide-wire assistance or the use of a new puncture site would have a lower complication rate than catheter exchange performed when clinically indicated.
An earlier randomized trial to evaluate scheduled replacement35 included 112 patients and 460 catheters and compared changes performed every seven days with either guide-wire assistance or the use of new puncture sites, with changes performed when clinically indicated with the use of new puncture sites. No significant differences in complication rates were found among the three groups, but infections and mechanical complications were slightly more frequent among patients in the scheduled-change groups than among those whose catheters were changed when indicated clinically.
The current trial also failed to show any trend favoring scheduled replacement. Thus, the fact that two trials detected no trend toward a reduced rate of bloodstream infection with the use of scheduled replacement suggests that there may be no benefit. When the results of the two trials are combined, the statistical power to detect a trend favoring scheduled replacement with an α value of 0.1 or 0.2 is 86 percent and 94 percent, respectively. The rates of catheter colonization, taken as a more sensitive indicator of the risk of catheter infection in many previous studies,1 , 13 14 15 16 , 18 19 20 , 22 , 23 , 25 , 35 36 37 38 , 41 42 43 44 , 46 , 51 , 52 also showed no trend favoring scheduled replacement in these two trials. The power to detect a trend in the rate of colonization favoring scheduled replacement was even higher than that cited above for bloodstream infections, because colonization occurs more frequently than bloodstream infection, making a reduction easier to detect.
Most studies of catheter-related infection have reported the number of infections occurring per catheter used.1 , 5 , 10 , 12 13 14 , 20 , 23 , 25 , 26 , 38 , 41 42 43 44 , 47 , 51 Analyzing our data according to the number of patients studied rather than the number of catheters used reveals an important pattern. The patients in group 2 (scheduled guide-wire—assisted exchange) had the highest rates of both catheter colonization (25 percent) and catheter-related bloodstream infection (10 percent), and all five catheter-related bloodstream infections that occurred more than 72 hours after the initial insertion of a catheter occurred in the two groups in which guide-wire—assisted exchange was used (P = 0.06).
Snyder et al.44 found more catheter-related infections among patients randomly assigned to undergo scheduled guide-wire—assisted exchange than among those randomly assigned to undergo scheduled exchange involving a new puncture site. This trend was reported as not statistically significant when analyzed on a per-catheter basis, but an analysis of the results on a per-patient basis (the unit of randomization in the study) shows that eight catheter infections were observed among the 30 patients who had guide-wire—assisted exchange, as compared with none among the 16 patients randomly assigned to exchange involving new puncture sites (P = 0.04) (Harrington G: personal communication). Two cohort studies also found a significantly higher risk of catheter-related infection after guide-wire—assisted exchange.9 , 42
Most previous studies have focused on the cumulative incidence of catheter-related infection1 , 2 3 4 5 6 7 , 11 12 13 14 15 16 , 18 19 20 , 22 , 23 , 25 , 26 , 28 29 30 , 37 , 38 , 42 43 44 , 47 , 51 , 52 rather than on the incidence rate. Stenzel and colleagues examined the incidence rate per day of catheter use as a function of the duration of catheterization at a given site and found that the incidence rate did not increase with the duration of catheterization.53 If the incidence rate remains constant, then changing catheters frequently will not reduce the cumulative incidence. The overall incidence rates of complications observed in this trial were similar to those observed in previous studies10 , 30 , 35 , 54 and did not appear to increase after the first three days of catheterization. Our study confirmed that exchange involving a new puncture site has a significantly higher risk of mechanical complications than guide-wire—assisted exchange, as reported in previous studies.30 , 38
Currently available data do not support the recommendation to change central catheters every three to four days — a process that entails increased use of physicians' and nurses' time, as well as increased hospital costs, and the risk of complications and discomfort for patients. If catheter exchange involves the use of new puncture sites, the rate of infectious complications does not appear to be reduced and the number of mechanical complications is definitely increased. If the exchange involves guide-wire assistance, the overall risk of bloodstream infection per patient appears to increase rather than decrease.
Until further data are available, we recommend that central venous catheters be placed with the use of optimal aseptic procedures and remain in place until there is a clinical indication for change, such as fever without a known source or a catheter malfunction. The low complication rates among patients in our groups 3 and 4, whose catheter replacements were managed in this way, suggest that this may be the safest and most practical way of managing such catheters. The results of this study should not be construed as a recommendation to leave catheters in place indefinitely, however. The total duration of catheter use (in one site or multiple sites) is correlated with the cumulative incidence of bloodstream infection; therefore, central venous catheters should be removed when no longer essential or when peripheral venous access is available and sufficient for the care of the patient.
Whether to replace a catheter with use of guide-wire assistance or a new puncture site remains a clinical decision in which the potential risks and benefits must be weighed for each patient. In the case of a catheter malfunction, a guide-wire—assisted exchange, with culture of the initial catheter, seems reasonable. In the presence of an obvious site infection, the catheter should be removed and a new puncture site used if central access is still required. If unexplained fever develops in a hemodynamically stable patient, the catheter may be changed in either manner, and the initial catheter should be cultured. A majority of new episodes of fever in such patients are not due to catheter-related infection, but the severe consequences of such infection justify the removal of the catheter for diagnostic purposes in these patients. If a culture of the initial catheter segment obtained through guide-wire assistance has ≥15 colony-forming units, then the replacement catheter should be removed and a new catheter inserted at a different site.36 , 41 For the minority of patients in intensive care units who require a central venous catheter for more than three days (<10 percent of the patients admitted to study units during this study), a silver-impregnated collagen cuff placed at the time of catheter insertion involving a new puncture site (but not guide-wire assistance) will significantly delay colonization and reduce the cumulative incidence of bloodstream infection due to bacteria or fungi (relative risk, 0.14; 95 percent confidence interval, 0.025 to 0.82; P = 0.03).1 , 52 Similar protection has recently been reported with the use of an antiseptic-coated catheter.55
Presented in part at the Interscience Conference on Antimicrobial Agents and Chemotherapy, Houston, September 1989, and Atlanta, October 1990.
We are indebted to Linda C. Wilson and Donna I. Consiglio for assistance with the preparation of the manuscript, to Kathleen McClure, Mary Bobbit, Linda Snead, and Lisa Durbin for technical assistance, and to the physicians and nurses of the University of Virginia.
Source Information
From the University of Virginia Health Sciences Center, Charlottesville. Address reprint requests to Dr. Farr at the Department of Medicine, Box 473, University of Virginia Health Sciences Center, Charlottesville, VA 22908.
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