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(Chest. 2000;118:1412-1418.)
© 2000 American College of Chest Physicians

A Meta-analysis of Prospective Trials Comparing Percutaneous and Surgical Tracheostomy in Critically Ill Patients*

Bradley D. Freeman, MD; Karen Isabella, RN; Natatia Lin, BS and Timothy G. Buchman, PhD, MD

* From the Department of Surgery, Section of Burn, Trauma, Surgical Critical Care, Washington University School of Medicine, St. Louis, MO.

Correspondence to: Bradley D. Freeman, MD, Department of Surgery, Section of Burn, Trauma, Surgical Critical Care, Washington University School of Medicine, Suite 6104, Box 8109, St. Louis, MO 63110; e-mail: freemanb{at}msnotes.wustl.edu


   Abstract
TOP
 Abstract
Introduction
 Materials and Methods
 Results
 Discussion
 Conclusion
 References
 
Study objectives: Tracheostomy is one of the most commonly performed procedures in the patient receiving long-term mechanical ventilation. While percutaneous dilational tracheostomy (PDT) is becoming increasingly utilized as an alternative to conventional surgical tracheostomy, most literature evaluating these two techniques is neither prospective nor controlled. We performed a meta-analysis of available prospective controlled studies comparing PDT and surgical tracheostomy in critically ill patients to more fully understand the relative benefits and risks of these two procedures in this population.

Design: Meta-analysis using Mantel-Haenszel fixed effect model.

Interventions: We performed searches of MEDLINE, Current Contents, Best Evidence, Cochrane, and HealthSTAR databases from 1985 to present to identify prospective controlled studies comparing PDT and surgical tracheostomy in critically ill patients. After establishing clinical and statistical homogeneity (Q statistic), studies were analyzed by a Mantel-Haenszel fixed effect model. For each clinical end point examined, PDT and surgical tracheostomy were compared by calculating either absolute differences or odds ratios (ORs) with 95% confidence intervals (CIs) for continuous or discrete variables, respectively.

Measurements and results: We pooled data from five studies (236 patients) satisfying our search criteria to analyze eight clinical end points. Operative time was shorter for PDT than surgical tracheostomy: absolute difference with 95% CI, 9.84 min (7.83 to 10.85 min). There was no difference comparing PDT and surgical tracheostomy with respect to overall operative complication rates: OR with 95% CI, 0.732 (0.05 to 9.37). However, relative to surgical tracheostomy, PDT was associated with less perioperative bleeding (OR with 95% CI, 0.14 [0.02 to 0.39]), a lower overall postoperative complication rate (OR with 95% CI, 0.14 [0.07 to 0.29]), as well as a lower postoperative incidence of bleeding (OR with 95% CI, 0.39 [0.17 to 0.88]), and stomal infection (OR with 95% CI, 0.02 [0.01 to 0.07]). No difference was identified in days intubated prior to tracheostomy (absolute difference with 95% CI, 0.16 days [- 0.9 to 1.22 days]), overall procedure-related complications (OR with 95% CI, 0.73 [0.06 to 9.37]), or death (OR with 95% CI, 0.63 [0.18 to 2.20]) comparing these two techniques.

Conclusions: Despite its popularity, there are currently only a limited number of small studies prospectively evaluating PDT and surgical tracheostomy. Our meta-analysis of these studies suggests potential advantages of PDT relative to surgical tracheostomy, including ease of performance, and lower incidence of peristomal bleeding and postoperative infection. If confirmed by additional, adequately powered prospective trials, these findings support PDT as the procedure of choice for the establishment of elective tracheostomy in the appropriately selected critically ill patient.

Key Words: mechanical ventilation • meta-analysis • outcomes • percutaneous dilational tracheostomy • prospective randomized trial • surgical infection • surgical tracheostomy


   Introduction
TOP
 Abstract
 Introduction
Materials and Methods
 Results
 Discussion
 Conclusion
 References
 
Tracheostomy is one of the most commonly performed surgical procedures in the critically ill patient requiring long-term mechanical ventilation.1 2

Traditionally, this procedure has been performed in the operating room using standard surgical principles.2 3 In 1985, Ciaglia et al4 described an alternative method in which tracheostomy is performed percutaneously, using a Seldinger approach (eg, percutaneous dilational tracheostomy [PDT]). Compared to surgically created tracheostomies (SCTs), this percutaneous method has a number of potential advantages. Specifically, PDT is relatively simple to learn and perform.5 As a consequence, even individuals who lack extensive surgical training may quickly become adept at this procedure.6 7 In addition, PDT may be performed at the patient’s bedside with a limited number of personnel,5 thus eliminating the potential risks associated with transporting a critically ill patient,8 as well as the inconvenience and expense of scheduling and utilizing operating room facilities. Because of these and other advantages, PDT is gaining increasing popularity.9

As experience has accumulated, it has become increasingly recognized that PDT is associated with complications not typically encountered with SCTs, including tracheal lacerations, tracheoesophageal fistula, and paratracheal insertion.7 10 11 12 13 Further, it is unknown if the frequency of major late complications of tracheostomy, such as tracheoinnominate artery fistula and symptomatic subglottic stenosis,2 differ substantially comparing these two techniques. To date, most of the studies comparing PDT and SCT are observational in design. Thus, the relative risks and advantages of PDT and SCT are, at present, incompletely studied in a prospective fashion.

Meta-analysis is a statistical technique used to systematically combine and analyze the results of individual clinical studies in an effort to more accurately assess therapeutic efficacy.14 15 Occasionally, such analyses reveal beneficial or harmful effects of a given treatment that are not apparent from consideration of individual studies.16 17 Currently, there exist a limited number of small prospective studies comparing PDT to SCT in critically ill patients requiring prolonged mechanical ventilation. Thus, we undertook a meta-analysis of these prospective studies in an effort to better understand the relative benefits and limitations of these two techniques in this patient population.


   Materials and Methods
TOP
 Abstract
 Introduction
 Materials and Methods
Results
 Discussion
 Conclusion
 References
 
Using the search term percutaneous tracheostomy, we performed searches of the MEDLINE, Current Contents, Best Evidence, Cochrane, and HealthSTAR databases from 1985 (the year that PDT was initially described4 ) to present to identify prospective studies comparing PDT and SCT. Our search was not restricted to English-language articles. We limited the studies for analysis to those that prospectively compared PDT to SCT in populations of critically ill patients requiring prolonged mechanical ventilation. Two authors (B.D.F. and T.G.B.) independently reviewed articles to determine that inclusion criteria were fulfilled, to categorize periprocedural and postprocedural complications, and to assess the techniques of PDT and SCT used. Once it was determined that the studies were clinically homogenous, statistical homogeneity was established (Q statistic), and the studies were analyzed by a Mantel-Haenszel fixed effect model.14 For continuous variables, we used the difference in mean values as the study effect estimate, with a negative value indicating a smaller value for the percutaneous technique, and a positive value indicating a smaller value for surgical tracheostomy. For discrete variables, we calculated the odds ratio (OR) comparing PDT and SCT, with a value < 1 indicating fewer complications associated with PDT, and a value greater > 1 indicating fewer complications associated with SCT. Standard statistical software packages (Excel; Microsoft; Redmond, WA; and Prism 3.0; Graphpad; San Diego, CA) were used.


   Results
TOP
 Abstract
 Introduction
 Materials and Methods
 Results
Discussion
 Conclusion
 References
 
Study Characteristics
Since 1985, 278 articles have been published on the technique of PDT. Of these, we identified six prospective studies that compared PDT to SCT.18 19 20 21 22 23 We excluded one study from our analysis because a large fraction of patients enrolled (60%) were not critically ill, and were undergoing tracheostomy as part of an elective procedure (tumor resection).23 We included the remaining five studies that enrolled 236 critically ill patients requiring tracheostomy for prolonged mechanical ventilation (115 undergoing PDT and 121 undergoing SCT) in our analysis.18 19 20 21 22 In three of these studies, treatment was assigned randomly,18 21 22 in one study, by week,20 and in one study, the method of treatment assignment was not specified.19 While all five studies provided information regarding patient age, gender, underlying medical conditions, and reasons necessitating prolonged mechanical ventilation, only three studies reported severity of illness indexes (APACHE [acute physiology and chronic health evaluation] II18 20 or simplified acute physiology score19 ). In three studies, PDT was performed in the ICU, while SCT was performed in the operating room18 19 20 ; in one study, both procedures were performed in the ICU22 ; and in one study, both procedures were performed in the operating room.21 All studies used the percutaneous dilational technique as described by Ciaglia et al4 and standard methods of creating a surgical tracheostomy.18 19 20 21 22 None of these studies included a power analysis or a priori estimates of effect size. In terms of quality, these studies would be graded level II according to the system proposed by Sackett,24 eg, small randomized trials with a moderate risk of either false-negative or false-positive results. These studies are summarized in Table 1 .


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  		Table 1.. Summary of Five Prospective Studies Comparing PDT and SCT*

 
Clinical End Points
To compare PDT and SCT, we abstracted data for eight clinical end points. These included procedure time, days intubated prior to tracheostomy, operative complications (all), operative bleeding, postoperative complications (all), postoperative bleeding, stomal infections, and death. Four studies reported operative time,18 19 21 22 and all five studies reported days intubated prior to tracheostomy. Two studies did not report operative complications.19 20 Friedman et al18 reported procedural complications as paratracheal insertion, transient hypotension, transient hypoxia, subcutaneous emphysema, minor bleeding (25 to 100 mL), loss of airway of > 20 s duration, and other. Similarly, Holdgaard et al21 reported operative complications as minor bleeding, major bleeding, cuff puncture, and resistance to insertion of the tracheostomy tube. These authors defined minor bleeding in the PDT group as bleeding that could be controlled by digital pressure, and major bleeding as bleeding that required additional measures to control. In the SCT group, minor bleeding was defined as bleeding controlled by electrocautery, and major bleeding was defined as bleeding sufficient to obscure the operative field, or which required suture ligature to control. Porter and Ivatory22 reported intraoperative complications as inability to place the tracheostomy tube, hypoxia, hypotension, loss of airway, and blood loss > 100 mL. Operative complications and their reported frequencies in these studies are summarized in Table 2 .


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  		Table 2.. Descriptions and Frequencies of Operative Complications

 
All five studies reported postoperative complications (summarized with their frequencies in Table 3 ). Hazard et al19 defined postoperative complications as hemorrhage (sufficient to require transfusion), stomal infection (presence of cellulitis), and pneumothorax. Similarly Crofts et al20 defined postoperative complications as major bleeding (requiring transfusion) or minor bleeding (requiring dressing change alone), pneumothorax, subcutaneous emphysema, cuff leak, atelectasis, and stomal infection (inflammation and purulent drainage requiring antibiotic therapy). Friedman et al18 defined postoperative complications as accidental decannulation, bleeding (small defined as 25 to 100 mL, moderate defined as 100 to 250 mL, and severe defined as > 250 mL), and stomal infection. Similarly, Holdgaard et al21 defined postoperative complications as bleeding (defined as for operative complications) and stomal infection (quantified as the distance in millimeters cellulitis extended from the stoma in conjunction with purulent sputum). Porter and Ivatury22 described postoperative complications as accidental decannulation, bleeding, pneumothorax, pneumomediastinum, infection, and local necrosis.


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  		Table 3.. Descriptions and Frequencies of Postoperative Complications

 
Meta-analysis
The time required to perform PDT was significantly less than that required for performing SCT: effect size with 95% confidence interval (CI) of - 9.84 min (- 7.83 to - 11.85 min). The interval between translaryngeal intubation and tracheostomy creation did not differ comparing these techniques: effect size with 95% CI of 0.16 (- 0.9 to 1.22 days). Likewise, considering all operative complications, there was no difference comparing techniques: OR with 95% CI, 0.73 (0.06 to 9.37). However, when operative bleeding alone was considered, the likelihood was less with PDT relative to SCT: OR with 95% CI, 0.15 (0.02 to 0.39). Further, PDT was less likely than SCT to result in all postoperative complications (OR with 95% CI, 0.15 [0.07 to 0.29]), postoperative bleeding (OR with 95% CI, 0.39 [0.18 to 0.88]), and stomal infections (OR with 95% CI, 0.02 [0.01 to 0.07]). Mortality rates did not differ comparing these techniques (OR with 95% CI, 0.63 [0.18 to 2.20]). These results are summarized in Figure 1 .



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  		Figure 1.. ORs with 95% CIs (represented by arrowheads and horizontal bars, respectively) for operative and postoperative complications comparing SCT and PDT. There was no difference comparing PDT and SCT with respect to overall operative complication rates: OR with 95% CI, 0.73 (0.06 to 9.37). However, relative to SCT, PDT was associated with less perioperative bleeding (OR with 95% CI, 0.15 [0.02 to 0.39]), a lower overall postoperative complication rate (OR with 95% CI, 0.15 [0.07 to 0.29]), as well as a lower postoperative incidence of bleeding (OR with 95% CI, 0.39 [0.18 to 0.88]), and stomal infection (OR with 95% CI, 0.02 [0.01 to 0.07]). Of note, an OR of 1.0 (indicated by the dashed line) indicates no difference between the two procedures.

 

   Discussion
TOP
 Abstract
 Introduction
 Materials and Methods
 Results
 Discussion
Conclusion
 References
 
Since its description in 1985, PDT has gained widespread acceptance as a method for creating an elective surgical airway in the patient requiring long-term mechanical ventilation.9 However, the benefits and risks of this technique, relative to conventional surgical approaches, have been determined largely from studies that are observational in design. In fact, our review identified only five small (ranging in enrollment from 24 to 60 patients) prospective studies comparing these two techniques in critically ill patients requiring prolonged mechanical ventilation.18 19 20 21 22 We used the methods of meta-analysis to combine and analyze the data presented in these individual studies in an effort to gain additional insight regarding the potential advantages and limitations of these two techniques. The studies appeared well matched with regard to both patient age and mortality. We analyzed these studies on the basis of eight clinical end points: time required to perform tracheostomy, duration of translaryngeal intubation prior to tracheostomy, procedural complications (all), procedure-related bleeding, postoperative complications (all), postoperative bleeding, stomal infections, and mortality. On the basis of our analysis, we found that PDT was performed more quickly, had a lower operative bleeding rate, and was associated with fewer postoperative complications than SCT. If confirmed by adequately powered prospective studies, this meta-analysis suggests that PDT may be the method of choice for tracheostomy creation in the appropriately selected patient receiving long-term mechanical ventilation.

A purported advantage of PDT, relative to conventional surgical techniques,3 centers on ease of performance.4 5 This advantage, as reflected by operative time, would appear supported by our analysis. On average, PDT was performed approximately 10 min more quickly than SCT. It seems unlikely, however, that this decrease in operative time is clinically significant. A second potential advantage of PDT compared to SCT emphasizes convenience.5 Specifically, PDT is a bedside procedure that avoids both the delays inherent in procedures performed in the operating room, and the potential risks and inconvenience associated with patient transport.5 We anticipated that this would be reflected in a shorter period of translaryngeal intubation in analysis of these studies. That is, once the decision to perform tracheostomy had been made, and the patient had been randomized to PDT, the procedure would be performed, and not delayed because of operating room scheduling. However, the duration of intubation prior to tracheostomy did not differ comparing these two techniques. This may be partly explained by the fact that in the study by Holdgaard et al,21 both procedures were performed in the operating room; in the study by Porter and Ivatury,22 both procedures were performed at the patient’s bedside. In either situation, no logistical advantage with respect to procedure scheduling or patient transport would be expected for PDT. Many authors have also emphasized the relative economy of PDT, compared to SCT.25 26 27 28 None of the prospective studies we evaluated compared these two techniques with respect to cost.18 19 20 21 22 Thus, while PDT may be advantageous with respect to both convenience and economy, these advantages are not obvious on the basis of the prospective studies reported to date, and remain important end points for further study in subsequent trials comparing these two techniques.

Examination of the five prospective studies individually did not reveal a consistent advantage of PDT compared to SCT with respect to complications.18 19 20 21 22 However, our meta-analysis revealed that relative to SCT, PDT was associated with lower rates of stomal bleeding and infection, as well as postoperative complications in general. One may speculate that the differences in rates of bleeding and infection can be explained by differences in the tracheostomy stoma following these two techniques. Specifically, following percutaneous placement, the stoma fits snugly around the tracheostomy tube. This lack of dead space conceivably serves to both tamponade bleeding vessels and to impede infection. In contrast, following surgical tracheostomy, the stoma fits loosely around the tracheostomy tube. Thus, no tamponading effect or barrier to infection occurs. This tamponading effect may similarly explain why PDT was associated with less operative bleeding in our analysis. It is less apparent, however, why PDT would be associated with less postoperative complications overall, since these included such diverse events as hemorrhage, infection, subcutaneous emphysema, cuff leak, and atelectasis (Table 3) . Further, differences in complication rates do not appear to be the result of differences in duration of translaryngeal intubation prior to tracheostomy. An important question in further prospective investigations will be to systematically study perioperative and postoperative complications comparing these two techniques. However, if the findings of our meta-analysis are confirmed, a lower complication rate would be a compelling reason favoring PDT over SCT.

Late sequelae of tracheostomy, in a small percentage of cases, include symptomatic tracheal stenosis and tracheoinnominate artery fistula.2 Neither of these complications were reported in any of the studies included in our analysis. Thus, based on available information, it is unclear whether there is any advantage of PDT compared to SCT with respect to preventing these adverse outcomes. Our analysis has an additional limitation. The studies we reviewed excluded patients for a variety of technical or anatomic factors that constitute relative or absolute contraindications to the performance of PDT.18 19 20 21 22 These include distortion of neck anatomy, prior neck surgery, cervical irradiation, maxillofacial or neck trauma, morbid obesity, a difficult airway, or marked coagulopathy. Surgical tracheostomy remains the method of choice in such patients.

The results of our meta-analysis differ from those of Dulguerov et al,29 who recently reported a meta-analysis comparing SCT and PDT. These authors found that PDT was associated with higher rates of serious perioperative complications (eg, death and cardiopulmonary arrest) relative to SCT.29 The differences in findings between these two meta-analyses may partly be attributable to the methodologies used. Dulguerov et al29 included both prospective and observational studies in a variety of patient populations over a long period of time (1960 to 1996). Further, studies were included in which PDT was performed by several techniques (eg, Ciaglia, Rapitrach, etc.). In contrast, we included only prospective studies comparing PDT and SCT in critically ill patient populations requiring tracheostomy for prolonged mechanical ventilation. Further, we only included studies in which PDT was performed as described by Ciaglia et al.4 As a consequence of our selection criteria, we excluded a large number of studies from our analysis. The exclusion of these studies may have potentially biased our results in favor of PDT. These and other factors (eg, publication bias, differing techniques of abstracting and analyzing data, etc.) may also explain why the results of meta-analyses at times differ substantially from the results of large randomized trials.14 15 30 Despite these shortcomings, meta-analysis remains a useful technique for analyzing the efficacy of therapies that have been evaluated chiefly by individual small trials.16 17 Collectively, our meta-analysis in conjunction with the analysis reported by Dulguerov et al29 raise important questions regarding the relative benefits of PDT and SCT that require further investigation.


   Conclusion
TOP
 Abstract
 Introduction
 Materials and Methods
 Results
 Discussion
 Conclusion
References
 
In summary, PDT has gained widespread acceptance despite the limited number of studies comparing it to conventional surgical technique. Our meta-analysis of prospective studies comparing PDT and SCT in critically ill patients suggests that PDT has some advantages relative to SCT, including ease of performance, and lower incidence of peristomal bleeding and postoperative infection. Whether there is any advantage of PDT compared to SCT with respect to either long-term complications or cost requires further study. Nevertheless, if the findings of our analysis are confirmed by adequately powered prospective trials, PDT may become the procedure of choice for establishing elective tracheostomy in patients receiving long-term mechanical ventilation.


   Footnotes
 
Abbreviations: CI = confidence interval; OR = odds ratio; PDT = percutaneous dilational tracheostomy; SCT = surgically created tracheostomy

Received for publication October 25, 1999. Accepted for publication March 22, 2000.


   References
TOP
 Abstract
 Introduction
 Materials and Methods
 Results
 Discussion
 Conclusion
 References
 

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Comparing percutaneous tracheostomy with open surgical tracheostomy
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