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P0.1 and Extubation Failure in Critically Ill Patients

NCT05802745 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2026-05-19

No results posted yet for this study

Summary

Weaning and extubation are essential steps for the management of critically ill patients when mechanical ventilation (MV) is no longer required. Extubation failure (EF) occurs in approximately 10-30% (1,2) of all patients meeting the readiness criteria and have tolerated a spontaneous breathing trial (SBT). EF is associated with prolonged MV, as well as increased morbidity and mortality (2). Therefore, the early identification of critically ill patients who are likely to experience EF is vital for improved outcomes.

EF can result from different factors (respiratory, metabolic, neuromuscular), particularly cardiac factor, and can be caused by the inability of the respiratory muscle pump to tolerate increases in the cardiac and respiratory load (1,3).

Respiratory drive represents the intensity of the neural stimulus to breathe. In mechanically ventilated patients, it can be abnormally low (i.e., suppressed or insufficient) or abnormally high (i.e., excessive), and thus result in excessively low or high inspiratory effort, leading to potential injury to the respiratory muscles (i.e., myotrauma) (4,5) or to the lungs. A high incidence of abnormal drive (low or high) may explain the high incidence of diaphragm dysfunction at time of separation from mechanical ventilation (6).

Airway occlusion pressure (P0.1) is the drop in airway pressure (Paw) 100 milliseconds after the onset of inspiration during an end-expiratory occlusion of the airway (7). P0.1 measurement is not perceived by the patient and does not influence respiratory pattern. It is, in theory, a reliable measure of respiratory drive because the brevity of the occlusion explains that it is not affected by patient's response to the occlusion and it is independent of respiratory mechanics (8). P0.1 has also been correlated with inspiratory effort (9, 10) and it has been shown that in patients under assisted mechanical ventilation P0.1 might be able to detect potentially excessive inspiratory effort (11).

P0.1 is a non-invasive measure and clinically available at bedside since currently nearly all modern ventilators provide a means of measuring it. Originally, a high P0.1 during a spontaneous breathing trial was associated with failure, suggesting that a high respiratory drive could predict weaning failure. However, only a few and old clinical studies investigated the association between P0.1 and extubation failure (EF) and were not conclusive (12,13). We hypothesized that patients with EF would have increased P0.1 values during spontaneous breathing trial (SBT). Therefore, the aims of our study will be to (1) to evaluate the ability of changes in P0.1 (Delta-P0.1) during SBT to predict EF and (2) to assess if Delta-P0.1 is an independent predictor of EF.

Conditions

  • Weaning Failure
  • Mechanical Ventilation
  • Critically Ill

Interventions

OTHER

Reintubation

Patients requiring re-intubation for acute respiratory failure.

Sponsors & Collaborators

  • Cleveland Clinic Abu Dhabi

    lead OTHER

Principal Investigators

  • Jihad Mallat, MD, PhD · Cleveland Clinic Abu Dhabi

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2024-05-25
Completion
2025-08-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05802745 on ClinicalTrials.gov