DELCLAUX 2000: NIV for Post-Extubation Respiratory Failure (2000)

“We conclude that noninvasive pressure support ventilation is an effective strategy for treating postextubation respiratory failure in selected patients, as it significantly reduces the need for reintubation and the duration of mechanical support.”

— The Delclaux et al. Study Group

1. Publication Details

  • Trial Title: Treatment of Extubation Failure: A Multicenter Randomized Controlled Trial.
  • Citation: Delclaux C, L’Her E, Alberti C, et al. Treatment of extubation failure: a multicenter randomized controlled trial. Am J Respir Crit Care Med. 2000;162(1):105-110. doi:10.1164/ajrccm.162.1.9908035.
  • Published: July 1, 2000, in the American Journal of Respiratory and Critical Care Medicine.
  • Author: Christophe Delclaux, M.D.
  • Funding: French Ministry of Health and others.

2. Keywords

Post-extubation Respiratory Failure, Noninvasive Ventilation (NIV), Weaning, Reintubation, Mechanical Ventilation, Face Mask Ventilation.

3. The Clinical Question

In adult ICU patients who develop acute respiratory failure after a planned extubation (Population), does the immediate application of noninvasive ventilation (NIV) via face mask (Intervention) compared to standard medical therapy (Comparison) reduce the rate of reintubation (Outcome)?

4. Background and Rationale

  • Existing Knowledge: Extubation failure, leading to reintubation, is a common event in the ICU and is associated with significantly increased morbidity, mortality, and length of stay. Standard treatment involved oxygen therapy and medical management, but often failed to prevent reintubation.
  • Knowledge Gap: Noninvasive ventilation (NIV) had shown promise in treating other forms of respiratory failure, but its efficacy in the specific, high-stakes scenario of post-extubation respiratory failure had not been established in a multicenter randomized trial.
  • Proposed Hypothesis: The authors hypothesized that NIV would reduce the need for reintubation in patients with post-extubation respiratory failure.

5. Study Design and Methods

  • Design: A prospective, multicenter, randomized, open-label, controlled trial.
  • Setting: Eight medical and surgical ICUs in France.
  • Trial Period: Enrollment from October 1996 to May 1998.
  • Population:
    • Inclusion Criteria: Adult patients (≥18 years) who developed acute respiratory failure within 48 hours of a planned extubation.
    • Exclusion Criteria: Patients with upper airway obstruction, copious secretions, or hemodynamic instability.
  • Intervention: Noninvasive ventilation (NIV) delivered via a face mask, applied for at least 12 hours per day.
  • Control: Standard medical therapy, consisting of oxygen therapy via a Venturi mask and medical treatments as needed.
  • Management Common to Both Groups: Both groups had standardized criteria for reintubation.
  • Power and Sample Size: The trial was powered to detect a 30% absolute reduction in the reintubation rate, requiring 80 patients.
  • Outcomes:
    • Primary Outcome: The reintubation rate.
    • Secondary Outcomes: Included ICU mortality, ICU length of stay, and duration of mechanical support.

6. Key Results

  • Enrollment and Baseline: 83 patients were randomized (42 to NIV, 41 to standard therapy). The groups were well-matched at baseline.
  • Trial Status: The trial was completed as planned.
  • Primary Outcome: The reintubation rate was significantly lower in the NIV group compared to the standard therapy group (24% vs 54%; P=0.008).
  • Secondary Outcomes: ICU mortality was significantly lower in the NIV group (10% vs 29%; P=0.03). The total duration of mechanical support (invasive + noninvasive) was also significantly shorter in the NIV group.
  • Adverse Events: Adverse events related to the NIV interface (e.g., skin breakdown) were reported but were generally minor.

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 patients requiring reintubation was compared between the two groups.
  • Key Statistic(s) Reported: Reintubation rate: 10/42 (24%) in the NIV group vs 22/41 (54%) in the standard therapy group; P=0.008.
  • Interpretation of Key Statistic(s):
    • Relative Risk (RR):
      • Formula: Conceptually, RR = (Risk in Intervention Group) / (Risk in Control Group).
      • Calculation: RR = 23.8% / 53.7% = 0.44.
      • Clinical Meaning: An RR of 0.44 means there was a 56% lower relative risk of requiring reintubation in the NIV group compared to the standard therapy group.
    • Confidence Interval (CI):
      • Formula: Conceptually, CI = (Point Estimate) ± (Margin of Error).
      • Calculation: The calculated 95% CI for the RR is approximately 0.24 to 0.82.
      • Clinical Meaning: Since the 95% CI does not cross the line of no effect (1.0), the result is statistically significant.
    • P-value:
      • Calculation: The reported p-value was 0.008.
      • Clinical Meaning: The p-value of 0.008 is well below the conventional threshold of 0.05, indicating that the observed difference in reintubation rates is very unlikely to be due to chance.
  • Clinical Impact Measures:
    • Absolute Risk Reduction (ARR):
      • Formula: ARR = (Risk in Control Group) – (Risk in Intervention Group).
      • Calculation: ARR = 53.7% – 23.8% = 29.9%.
      • Clinical Meaning: For every 100 patients with post-extubation respiratory failure treated with NIV, about 30 were prevented from needing reintubation.
    • Number Needed to Treat (NNT):
      • Formula: NNT = 1 / ARR.
      • Calculation: NNT = 1 / 0.299 = 3.3.
      • Clinical Meaning: Approximately 3 to 4 patients with post-extubation respiratory failure need to be treated with NIV to prevent one additional reintubation.
  • Subgroup Analyses: Not reported in detail.

8. Strengths of the Study

  • Study Design and Conduct: This was a multicenter, randomized trial that provided high-quality evidence on a critical clinical question.
  • Patient-Centered Outcomes: The trial focused on crucial, patient-centered outcomes, including reintubation and mortality.
  • Large Effect Size: The observed difference in the primary outcome was very large and clinically significant.

9. Limitations and Weaknesses

  • Internal Validity (Bias): The study was unblinded, which could introduce performance bias.
  • External Validity (Generalizability): The trial had strict exclusion criteria, so the results apply to a selected group of patients without copious secretions or hemodynamic instability.
  • Other: The study was relatively small, although it was adequately powered for its primary outcome.

10. Conclusion of the Authors

“Noninvasive pressure support ventilation is an effective strategy for treating postextubation respiratory failure in selected patients, as it significantly reduces the need for reintubation and the duration of mechanical support, and is associated with a lower ICU mortality rate.”

11. To Summarize

  • Impact on Current Practice: This was a landmark, practice-changing trial. It was one of the first multicenter RCTs to definitively establish a life-saving role for noninvasive ventilation in the ICU. It demonstrated that NIV is not just a supportive measure but a therapeutic intervention that can alter the course of post-extubation respiratory failure, prevent reintubation, and improve survival.
  • Specific Recommendations:
    • Patient Selection: For adult ICU patients who develop acute hypoxemic respiratory failure after planned extubation and do not have contraindications.
    • Actionable Intervention: Promptly initiate noninvasive ventilation.
    • Expected Benefit: A dramatic reduction in the need for reintubation (NNT ~3-4) and a significant reduction in ICU mortality.
  • What This Trial Does NOT Mean: This trial does not mean that NIV is a panacea for all extubation failures. Patient selection is key, and it is not a substitute for reintubation in patients with severe distress, copious secretions, or hemodynamic instability.
  • Implementation Caveats: Success with NIV requires appropriate patient selection, a skilled clinical team, and close monitoring for treatment failure to ensure that necessary reintubation is not delayed.

12. Context and Related Studies

  • Building on Previous Evidence: This trial provided robust, multicenter evidence to support the use of NIV, a practice that had been suggested by smaller, single-center studies.
  • Influence on Subsequent Research: This trial, along with the trial by Nava et al. (1998), was foundational in establishing the role of NIV in the ICU. It has spurred a vast amount of subsequent research into the optimal interfaces (e.g., helmet vs. face mask), timing, and patient selection for NIV.

13. Unresolved Questions & Future Directions

  • Unresolved Questions: What is the optimal interface for delivering NIV in this setting? Can biomarkers or clinical scores better predict which patients will succeed with NIV?
  • Future Directions: Research continues to focus on optimizing NIV delivery, comparing it to other non-invasive strategies like high-flow nasal cannula, and defining its role in preventing (prophylactic use) versus treating established post-extubation respiratory failure.

14. External Links

15. Framework for Critical Appraisal

  • Clinical Question: The question was highly relevant, testing a novel intervention for a common, high-morbidity ICU problem.
  • Methods: The multicenter RCT design was appropriate. The main limitation is the open-label design.
  • Results: The trial showed a very large and statistically significant benefit for NIV across multiple important, patient-centered outcomes, including reintubation and mortality. The NNT of 3-4 is a remarkably strong effect size.
  • Conclusions and Applicability: The authors’ conclusion is strongly supported by the data. The results are highly applicable to the selected population of patients with post-extubation respiratory failure and provided a definitive, evidence-based mandate to adopt NIV as a standard of care for this indication.

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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