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| Abstract |
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Methods Published studies on the use of compression and pneumatic devices in intensive care patients were assessed. A meta-analysis was conducted by using the randomized controlled trials.
Results A total of 21 relevant studies (5 randomized controlled trials, 13 observational studies, and 3 surveys) were found. A total of 811 patients were randomized in the 5 randomized controlled trials; 3421 patients participated in the observational studies. Trauma patients only were enrolled in 4 randomized controlled trials and 4 observational studies. Meta-analysis of 2 randomized controlled trials with similar populations and outcomes revealed that use of compression and pneumatic devices did not reduce the incidence of venous thromboembolism. The pooled risk ratio was 2.37, indicative of favoring the control over the intervention in reducing the deep venous thrombosis; however, the 95% CI of 0.57 to 9.90 indicated no significant differences between the intervention and the control. A range of methodological issues, including bias and confounding variables, make meaningful interpretation of the observational studies difficult.
Conclusions The limited evidence suggests that use of compressive and pneumatic devices yields results not significantly different from results obtained with no treatment or use of low-molecular-weight heparin. Until large randomized controlled trials are conducted, the role of mechanical approaches to thromboprophylaxis for intensive care patients remains uncertain.
| Pulmonary embolus is life threatening in critically ill patients and has a 30% mortality rate.
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Most of these guidelines, however, are for medical or surgical patients9 and cannot be extrapolated to intensive care patients. As a result, the possibility that the benefit-to-risk ratio for venous thromboembolism in intensive care patients may be different from that in other patients also must be considered.6
| Mechanical Prophylaxis |
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Dynamic approaches for prevention of DVT include devices that provide intermittent pneumatic compression of either the foot, the calf, or the calf and thigh. The compression is generated by an external electrical compressor that intermittently inflates a cuff or sleeve applied over one or more of those anatomical areas. These devices are broadly known as pneumatic compression devices or sequential compression devices. Their mechanism of action relies on either graded circumferential or uniform intermittent compression.
The potential benefit of mechanical thromboprophylaxis can be viewed from 2 perspectives. First, mechanical thromboprophylaxis may be useful as an interim or alternative measure until pharmacological prophylaxis can be safely introduced. That is, mechanical approaches can be used in patients in whom pharmacological agents are either contraindicated or in whom the likelihood of "catastrophic" bleeding poses an unacceptable risk.12 Second, mechanical approaches may act in a synergistic manner and as a result provide additional protective benefit when combined with mainstay pharmacological prophylaxis.7 This benefit, however, has yet to be demonstrated empirically in intensive care patients.
| Objective |
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| Mechanical prophylaxis consists of graded compression stockings and pneumatic compression devices.
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| Methods |
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Studies were included if the study samples consisted of intensive care patients, including trauma, surgical, medical, and coronary patients. Studies were excluded if they indicated that intensive care patients were included but did not provide a breakdown into subgroups of intensive care patients. We had no language restrictions, but we were able to review only the abstracts of non-English publications. Potentially relevant citations were evaluated for inclusion in duplicate by 2 of us (WC, AL).
In duplicate and independently, 2 researchers (WC, EM) abstracted data on the study design, population, intervention, diagnostic tests, and outcomes, assessing the methodological quality of each aspect. This assessment was informed by the Cochrane handbooks description of assessing study quality by considering the potential influence of selection, performance, detection, and attrition bias.13 These concepts resulted in detailed documentation of (1) the sample including the population, sample size, and response rates (if applicable); (2) the intervention (if applicable); (3) the diagnostic tests used to assess the outcome (if applicable); and (4) the actual outcome measured. When discrepancies arose, the studies were reviewed again and the issues were resolved by consensus.
For the 2 randomized controlled trials (RCTs), a meta-analysis was conducted to obtain the combined risk ratio estimates for the differences in the effects due to intervention and control with compression and pneumatic devices in intensive care patients. Meta-analysis has been defined as "the statistical combination of results from two or more separate studies."14 Data were analyzed as rate data, that is, the incidence of DVT in each group. The pooled risk ratio was estimated by using both fixed and random effects models. Results were summarized in a forest plot, also termed a confidence interval plot. This plot displays estimates of the treatment effects of the individual studies and the estimate from the meta-analysis. Any publication bias among these RCTs was assessed by using a funnel plot. A funnel plot is "a scatterplot of treatment effect against a measure of study size"15 and is used to detect bias schematically. If publication bias is unlikely, then a symmetric inverted funnel shape is displayed, with asymmetry suggesting either publication bias or systematic differences between small and large studies.
| Results |
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Randomized Controlled Trials
Five RCTs1620 were found that included mechanical methods of DVT prophylaxis in intensive care patients (Table 1
). A total of 811 patients were involved in all 5 trials (range 20442). Patients in the trials included trauma patients1720 and myocardial infarction patients aged more than 70 years.16 Blinded outcome assessment was used in only 1 of the 5 studies.19
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Of the 5 RCTs, only 2 qualified for the meta-analysis because of their comparable samples (trauma patients), treatment comparisons (ie, compression and pneumatic devices vs low-molecular-weight heparin), and outcomes (incidence of vascular thromboembolism). In the 3 excluded RCTs, Elliott et al17 compared 2 compression and pneumatic devices, Murakami et al18 examined the compliance between 2 compression and pneumatic devices, and Kierkegaard and Norgren16 compared GCS with no GCS in older patients with myocardial infarction.
Meta-analysis results revealed that the point estimate of the risk ratio obtained from the random effects model was 2.37, indicative of favoring the control over the intervention for the DVT outcome (Table 2
). However, the 95% CI of 0.57 to 9.90 indicated no significant differences between the intervention and the control. The fixed model also yielded consistently similar estimates of 2.56 (95% CI 0.788.37) as shown in the forest plot (see Figure
). The funnel plot was symmetrical, and because both the meta-analysis and 1 of the 2 studies in it favored the control it is unlikely that publication bias exists in this research.
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Seven studies3,4,22,24,25,28,29 included either incidence or prevalence of DVT as a measure, which represented a total of 1775 patients. Incidence of DVT in intensive care patients ranged from 11%22 to 56%24 if no treatment was used, 7.4%25 to 40%24 when pharmacological prophylaxis was used, and 0%22 to 33%24 when mechanical prophylaxis was used. Two studies had incidences of 13%28 and 31%29 for combination of pharmacological and mechanical prophylaxis. In 4 studies,23,27,30,31 the use of mechanical devices and drugs for DVT prophylaxis was documented. In another 4 studies24,25,28,29 with a total of 495 patients, mechanical prophylaxis was compared with pharmacological prophylaxis in relation to either the incidence or prevalence of DVT.
In the 3 studies25,28,29 in which the researchers undertook further analysis, no significant difference was found between the 2 forms of treatment for reducing the incidence of DVT. However, because of their small samples, the power of these studies must be questioned, because the true efficacy of pharmacological and mechanical prophylaxis may not have been recognized. In the reports of 2 studies,21,26 the authors also described the correct application and maintenance of mechanical devices.
Because observational studies are not designed to evaluate effectiveness,35 conclusions about the use of pneumatic and compression devices cannot be drawn. Direct observation of venous thromboembolism was reported in 7 studies3,4,2225,28; however, a range of methodological issues, including the potential for bias and confounding, make meaningful interpretation difficult and problematic.
Surveys
We found 3 surveys3234 in which researchers queried clinicians about the use of mechanical measures for thromboprophylaxis in the context of current clinical practices (Table 4
). In total, 445 clinicians were surveyed in these 3 studies, representing 290 intensive care units in Canada, Australia, and Germany. Cook et al32 found that 17 (58.6%) of the 29 Canadian medical directors surveyed incorporated GCS as part of routine DVT prophylaxis for the 3 risk categories (recent bleeding, active bleeding, and high risk of bleeding). Pneumatic compression devices were used less frequently; 12 medical directors (41.4%) reported the use of these devices in patients with a recent history of bleeding.
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These studies suggest that practices vary widely within countries and throughout the world. Most likely the lack of definitive evidence is a significant contributing factor to these variations in clinical practice.
| Discussion |
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A systematic review39 of all relevant RCTs included evidence supporting the effectiveness of intermittent pneumatic compression, GCS, and GCS in combination with low-dose heparin in moderate risk, general surgical patients. No equivalent evidence to guide practice in high-risk critical care patients was found.
Little evidence is available on the mechanical methods of DVT prophylaxis in critically ill patients. Not only have few trials been done, but the overall numbers of patients in the trials are extremely small. Thus, few RCTs are available to provide guidance for practice. In contrast, a large number of observational studies indicate that compression and pneumatic devices are used widely in practice.
| Although a large number of studies indicate that mechanical devices are widely used, few clinical trials are available to provide guidance for practice.
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The observational study data are predominantly from North America, where the use of unfractionated heparin is the DVT prophylaxis of choice. In Europe, unlike North America, low-molecular-weight heparin is used predominantly. An Australian survey indicates that mechanical approaches to DVT prevention are common there.34 The observational data suggest that use of mechanical strategies for DVT prevention is widespread. The overall approach, however, is rather ad hoc or based on tradition because no guidelines based on evidence exist. Although 28.8% of the patients in the observational trials were trauma patients who did not receive anticoagulants, these data are no longer helpful in interpreting the results because strong data that support the use of low-molecular-weight heparin in this population are now available.4042
Surveys of stated practice helped inform our systematic review, in that these studies provide useful indicators of current practices as perceived by those responding to the surveys. Three prospective multicenter surveys met our inclusion criteria: 1 study each from Australia,34 Canada,32 and Germany.33 These survey data represent opinions of 264 clinicians (29 physicians and 235 nurses). These survey results suggest that clinical practice varies widely, both within and between countries.
| Graded compression stockings are used inappropriately, and their application is variable.
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Our review suggests that GCS are not properly used to prevent venous thromboembolism. In addition to improper use of GCS, the frequency of use of GCS is also variable. It is therefore not unreasonable to assume that similar deficiencies may exist with other mechanical devices. Perhaps these deficiencies associated with mechanical strategies relate to a lack of empirical evidence. This lack of empirical evidence means that no guidelines have been clearly accepted, and thus practice varies widely.
The aim of future trials should be to determine what additional protective benefit compression and pneumatic devices provide when combined with mainstay pharmacological prophylaxis. Because this added benefit may be small, large-scale multisite trials will most likely be required. In designing these trials, researchers should recognize that clinical factors such as incorrect application or unplanned removal of devices may affect the study results. Another important consideration for future researchers is the type of tests used to diagnose DVT and their frequency of use; future comparisons would be more relevant if similar diagnostic criteria and measurements could be used.
The methods used in the upcoming PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT)42 may provide a basis and guidance for researchers designing future studies of mechanical thromboprophylaxis.
| Summary |
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To purchase electronic or print reprints, contact The InnoVision Group, 101 Columbia, Aliso Viejo, CA 92656. Phone, (800) 809-2273 or (949) 362-2050 (ext 532); fax, (949) 362-2049; e-mail, reprints{at}aacn.org.
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When critically appraising this issues AJCC journal club article, "Mechanical Thromboprophylaxis in Critically Ill Patients: A Systematic Review and Meta-Analysis," consider the questions and discussion points listed below.
Study Synopsis: Compression and pneumatic devices are commonly used in the intensive care unit (ICU) to prevent thromboemboli in critically ill patients. This article reports on the results of a systematic review of randomized clinical trials evaluating the effect of compression and pneumatic devices on thromboprophylaxis in critically ill patients. Twenty-one studies identified in the literature, including 5 randomized clinical trials, were evaluated for their impact on reducing the incidence of venous thromboembolism in ICU patients. A meta-analysis of the 5 randomized clinical trials that included 811 patients revealed no significant differences between intervention and controls. The results of the meta-analysis indicate that limited evidence exists to suggest that compression and pneumatic devices are significantly different from no treatment or use of low-molecular-weight heparin.
Information From the Authors: Anthony Limpus, RN, lead author of this journal club article, provided additional information about the study. Limpus explains that the team decided to conduct the meta-analysis to critically evaluate the effect of a relatively common ICU practice as well as to extend the research evidence. He relates: "The background is that the meta-analysis is part of a program of research that aims to provide the evidence as to the ideal length of graduated compression stocking for use in the critically ill. We did not plan to conduct the meta-analysis when we first started, but as the program matured it became apparent that it would be a good idea to undertake, as it would support our credentials to attract funding for larger studies in the area of mechanical thromboprophylaxis."
Limpus shares that the team has conducted several previous studies related to thromboprophylaxis, including a national audit on the use of graduated compression stockings in Australian ICUs, the effect of body position and graduated compression stocking length on blood flow velocity in the femoral vein, and compression profiles of graduated compression stockings following repetitive use by patients and hospital laundering, among other studies.
Limpus also shares that the most surprising finding of the meta-analysis was the lack of effect: "Obviously the finding from the 2 [randomized clinical trials] that there were no significant differences between the intervention and control stands out. However, the striking thing for me was that nobody has yet come to terms with the issues (difficulties) related to designing appropriate studies investigating pneumatic and compression devices. I think there needs to be a change in the mindset of researchers to possibly view these devices much the same as drugs. By that I mean to demonstrate efficacy we need to somehow quantify the patients exposure or dose of mechanical thromboprophylaxis."
Implications for Practice: According to the meta-analysis, the effect of the use of compression and pneumatic devices on thromboprophylaxis remains uncertain. Limpus suggests that "the major implication for the readership is to increase the awareness of the importance of compression and pneumatic devices. As nurses we have a responsibility to ensure that the appropriate devices are selected, correctly sized, and applied and then maintained."
"Hopefully," Limpus concludes, "this meta-analysis might act as a catalyst for further inquiry to either demonstrate efficacy in the critical care population, stimulate ongoing debate to question their use, and/or reduce the factors that limit their performance (appropriate selection, correct sizing and application). Either way, this meta-analysis has highlighted that study of compression and pneumatic devices is a huge area of opportunity for nurse researchers."
Journal Club feature commentary is provided by Ruth Kleinpell.
This article has been cited by other articles:
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W. H. Geerts, D. Bergqvist, G. F. Pineo, J. A. Heit, C. M. Samama, M. R. Lassen, and C. W. Colwell Prevention of Venous Thromboembolism: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition) Chest, June 1, 2008; 133(6_suppl): 381S - 453S. [Abstract] [Full Text] [PDF] |
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G. Piazza, A. Seddighzadeh, and S. Z. Goldhaber Double Trouble for 2,609 Hospitalized Medical Patients Who Developed Deep Vein Thrombosis: Prophylaxis Omitted More Often and Pulmonary Embolism More Frequent Chest, August 1, 2007; 132(2): 554 - 561. [Abstract] [Full Text] [PDF] |
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