TracMan: Early vs Late Tracheostomy in the ICU (2013)

“In this study of critically ill adult patients, a policy of early tracheostomy (within 4 days of admission) did not result in a lower 30-day mortality rate than a policy of late tracheostomy (after 10 days).”

— The TracMan Collaborators

1. Publication Details

  • Trial Title: Effect of early vs late tracheostomy placement on survival in patients receiving mechanical ventilation: the TracMan randomized trial.
  • Citation: Young D, Harrison DA, Cuthbertson BH, et al; for the TracMan Collaborators. Effect of early vs late tracheostomy placement on survival in patients receiving mechanical ventilation: the TracMan randomized trial. JAMA. 2013;309(20):2121-2129. doi:10.1001/jama.2013.5154.
  • Published: May 22, 2013, in The Journal of the American Medical Association (JAMA).
  • Author: Duncan Young, F.R.C.A.
  • Funding: UK National Institute for Health Research Health Technology Assessment Programme.

2. Keywords

Tracheostomy, Mechanical Ventilation, Weaning, Critical Illness, Timing, Sedation.

3. The Clinical Question

In adult critically ill patients predicted to require prolonged mechanical ventilation (Population), does a policy of early tracheostomy (≤4 days) (Intervention) compared to a policy of late tracheostomy (≥10 days) (Comparison) reduce 30-day all-cause mortality (Outcome)?

4. Background and Rationale

  • Existing Knowledge: Tracheostomy is a common procedure for patients requiring long-term mechanical ventilation. It is thought to improve patient comfort, reduce sedation needs, and facilitate weaning.
  • Knowledge Gap: The optimal timing for performing a tracheostomy was highly debated. It was unclear if performing the procedure “early” provided a survival advantage or if a “late” approach, which would avoid the procedure altogether in patients who extubated quickly, was superior. Previous trials were small and had conflicting results.
  • Proposed Hypothesis: The authors hypothesized that a policy of early tracheostomy would reduce 30-day mortality compared with a policy of late tracheostomy.

5. Study Design and Methods

  • Design: A prospective, multicenter, randomized, controlled trial.
  • Setting: 70 intensive care units (ICUs) in the United Kingdom.
  • Trial Period: Enrollment from November 2004 to April 2011.
  • Population:
    • Inclusion Criteria: Adult patients (≥18 years) who had been intubated for less than 4 days and were deemed by their treating clinician to have a likely need for mechanical ventilation for at least 7 more days.
    • Exclusion Criteria: Clinical indication for immediate tracheostomy or a contraindication to the procedure.
  • Intervention: A policy of early tracheostomy, to be performed as soon as possible and no later than day 4 of ICU admission.
  • Control: A policy of late tracheostomy, where patients were managed with ongoing endotracheal intubation. A tracheostomy was only performed if the patient still required it on or after day 10 of ICU admission.
  • Management Common to Both Groups: All other aspects of critical care, including sedation and weaning practices, were at the discretion of the local clinical team.
  • Power and Sample Size: The trial was powered to detect a 7.5% absolute difference in 30-day mortality, requiring 900 patients.
  • Outcomes:
    • Primary Outcome: All-cause mortality at 30 days.
    • Secondary Outcomes: Included mortality at 1 and 2 years, duration of mechanical ventilation, ICU length of stay, and sedative use.

6. Key Results

  • Enrollment and Baseline: 909 patients were randomized (455 to early tracheostomy, 454 to late tracheostomy). The groups were well-matched at baseline.
  • Trial Status: The trial was completed as planned.
  • Primary Outcome: There was no significant difference in 30-day mortality between the early and late tracheostomy groups (30.8% vs 31.5%; P=0.77).
  • Secondary Outcomes: There were no significant differences in mortality at 1 or 2 years, or in ICU or hospital length of stay. The early tracheostomy group had a shorter duration of sedation in the first 30 days. A key finding was that 45% of patients in the late tracheostomy group were successfully extubated without ever needing the procedure.
  • Adverse Events: The rates of procedure-related complications were low and similar between the two groups.

7. Medical Statistics

  • Analysis Principle: An intention-to-treat analysis was performed.
  • Statistical Tests Used: The primary outcome was analyzed using a chi-square test.
  • Primary Outcome Analysis: The proportion of deaths at day 30 was compared between the two groups.
  • Key Statistic(s) Reported: Relative Risk (RR) for death at 30 days with early tracheostomy: 0.98 (95% CI, 0.80 to 1.19; P=0.77).
  • Interpretation of Key Statistic(s):
    • Relative Risk (RR):
      • Formula: Conceptually, RR = (Risk in Intervention Group) / (Risk in Control Group).
      • Calculation: The paper reports the RR as 0.98.
      • Clinical Meaning: An RR of 0.98 means there was a 2% lower relative risk of death in the early tracheostomy group, a difference that is not statistically significant.
    • Confidence Interval (CI):
      • Formula: Conceptually, CI = (Point Estimate) ± (Margin of Error).
      • Calculation: The reported 95% CI was 0.80 to 1.19.
      • Clinical Meaning: Since this confidence interval is centered around the line of no effect (1.0) and is relatively narrow, it provides a precise estimate that there is no significant difference between the two strategies. The true effect is likely somewhere between a 20% benefit and a 19% harm.
    • P-value:
      • Calculation: The reported p-value was 0.77.
      • Clinical Meaning: The p-value of 0.77 is far above the 0.05 threshold, confirming that the observed result is very likely due to chance. A result is conventionally considered statistically significant if the p-value is less than 0.05.
  • Clinical Impact Measures:
    • Absolute Risk Reduction (ARR):
      • Formula: ARR = (Risk in Control Group) – (Risk in Intervention Group).
      • Calculation: ARR = 31.5% – 30.8% = 0.7%.
      • Clinical Meaning: The intervention was associated with a non-significant 0.7% absolute reduction in the risk of death at 30 days.
    • Number Needed to Treat (NNT): Not applicable, as the intervention showed no benefit.
  • Subgroup Analyses: No significant benefit was found in any of the pre-specified subgroups.

8. Strengths of the Study

  • Study Design and Conduct: This was a large, pragmatic, multicenter randomized trial that provided a robust answer to a common and important clinical question.
  • Generalizability: The inclusion of 70 diverse ICUs and a broad population of critically ill patients increases the external validity of the findings.
  • Patient-Centered Outcomes: The primary outcome of 30-day mortality is a strong, patient-centered endpoint.

9. Limitations and Weaknesses

  • Internal Validity (Bias): The study was unblinded, which is a potential source of bias, though the primary outcome of mortality is objective. Clinician prediction of the need for prolonged ventilation is known to be inaccurate, which is a limitation of the study’s inclusion criteria.
  • External Validity (Generalizability): The results may not apply to specific populations with a very high likelihood of prolonged ventilation, such as those with severe neurologic injury.
  • Other: The trial did not find a difference in mortality, but the early group did receive fewer sedatives. The clinical importance of this is unclear.

10. Conclusion of the Authors

“In this trial of adult patients in the ICU, a policy of early tracheostomy was not associated with a lower rate of 30-day mortality than a policy of late tracheostomy.”

11. To Summarize

  • Impact on Current Practice: The TracMan trial was a landmark study that largely settled the “early vs. late” tracheostomy debate for the general ICU population. It provided strong evidence that a routine policy of early tracheostomy does not improve survival. This supports a more watchful-waiting approach, which avoids an invasive procedure in the nearly half of patients who can be liberated from ventilation before day 10.
  • Specific Recommendations:
    • Patient Selection: For the general population of critically ill adults requiring mechanical ventilation.
    • Actionable Intervention: A policy of delaying tracheostomy until at least day 10 is a safe and appropriate strategy.
    • Expected Benefit: No difference in mortality. A late tracheostomy policy avoids the procedure in a substantial number of patients (45% in this trial).
  • What This Trial Does NOT Mean: This trial does not mean that early tracheostomy should never be performed. The decision can still be individualized based on specific patient factors, such as profound airway needs, patient comfort, or anticipated very long-term ventilation.
  • Implementation Caveats: The key is to recognize that clinician prediction of who needs a tracheostomy is often inaccurate, and a period of continued weaning efforts is warranted.

12. Context and Related Studies

  • Building on Previous Evidence: TracMan was the largest and most definitive trial on this topic, designed to resolve the conflicting findings from numerous smaller, single-center studies.
  • Influence on Subsequent Research: This trial’s findings have been highly influential and are reflected in international guidelines. Subsequent research has focused on specific populations not well-represented in TracMan, such as the SETPOINT2 trial (2022), which studied patients with severe stroke.

13. Unresolved Questions & Future Directions

  • Unresolved Questions: What is the optimal timing of tracheostomy in specific, homogeneous populations, such as those with severe traumatic brain injury or other forms of neurologic devastation?
  • Future Directions: Research is ongoing to develop better predictive tools to identify which patients will truly benefit from a tracheostomy, thereby avoiding both unnecessary delays and unnecessary procedures.

14. External Links

15. Framework for Critical Appraisal

  • Clinical Question: The question was highly relevant and pragmatic, addressing a common and resource-intensive decision point in critical care.
  • Methods: The large, multicenter RCT design was methodologically strong and provided a high level of evidence.
  • Results: The trial had a clear and robustly neutral result for its primary outcome of mortality. The finding that 45% of patients in the late group avoided tracheostomy altogether was a critically important secondary finding.
  • Conclusions and Applicability: The authors’ conclusion is a direct and fair interpretation of the data. The results are highly applicable to the general ICU population and provide a strong evidence base to support a more conservative, watchful-waiting approach to the timing of tracheostomy.

16. Disclaimer and Contact

This summary is provided by the Academic Committee of ESBICM (ACE) to facilitate the understanding of this study; readers are advised to refer to the original trial document for a deeper understanding. If you find any information incorrect, or missing, or it needs an update or have a request for a specific critical care trial summary, kindly write to us at academics[at]esbicm.org.

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