Association Between P0.1 and Extubation Failure in Adult Patients with Acute Hypoxemic Respiratory Failure. a Multicenter Prospective Cohort Study

Active, not recruiting

• Conditions: Ventilator Weaning

• Registration Number: NCT06662201
• Lead Sponsor: Argentinian Intensive Care Society

Brief Summary

The goal of this observational study is to learn about the effect of the occlusion pressure during the first 100 miliseconds (P01) over the extubation failure in participants receiving mechanical ventilation for acute respiratory failure.

The main question it aims to answer is:

Are high P0.1 values (≥3 cmH2O) measured 30 minutes after starting a spontaneous breathing trial associated with extubation failure in adult patients who were intubated for acute hypoxemic respiratory failure?

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-29
• Status Verified: 2024-09
• Study First Submitted: 2024-10-25
• Study First Submitted QC: 2024-10-25
• Last Update Submitted: 2024-10-25
• Study First Posted: 2024-10-28
• Last Update Posted: 2024-10-28
• Primary Completion: 2025-08-29
• Study Completion: 2025-08-29

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 256

Inclusion Criteria

• Patients over 17 years of age
• Patients receiving invasive mechanical ventilation for more than 24 hours
• Patients who have been ventilated for acute hypoxemic respiratory failure
• Patients who overcome a PVE
• Patients who, after overcoming the PVE, meet the conditions to be extubated immediately after, according to the team of treating professionals who conduct the weaning
• Patients who are in their first attempt at extubation

Exclusion Criteria

• Tracheostomized patients
• Patients with neuromuscular disease (For example: Guillain Barré,
• Myasthenia Gravis, Amyotrophic lateral sclerosis, etc.)
• Patients with a decision not to reintubate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Extubation failure	From enrollment to the end of follow-up at day 7	Extubation failure is defined as reintubation by day 7. The decision to reintubate a patient will be made by the treating team, who will be blinded to the P0.1 values measured during spontaneus breathing trial.

Secondary Outcome Measures

Name	Time	Method
Cut-off point of P01	From enrollment to the end of follow-up at day 7	To identify the best cut-off point of P0.1 to predict extubation failure in adult patients who required invasive mechanical ventilation for acute hypoxemic respiratory failure.

Trial Locations

Locations (1)

Sanatorio Anchorena Recoleta; 🇦🇷 Ciudad Autónoma de Buenos Aires, Argentina