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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06662201

Enrollment

256

Registered

2024-10-28

Start date

2024-08-29

Completion date

2025-08-29

Last updated

2024-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilator Weaning

Keywords

Respiration, artificial, Positive-Pressure Respiration

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?

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Argentina

Outcome results