Clinical trial NCT06662201: Association Between P0.1 and Extubation Failure in Adult Patients with Acute Hypoxemic Respiratory Failure. a Multicenter Prospective Cohort Study
Official title: Association Between P0.1 and Extubation Failure in Adult Patients with Acute Hypoxemic Respiratory Failure. a Multicenter Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Ventilator Weaning
Keywords: Respiration, artificial
Positive-Pressure Respiration
Lead sponsor: Argentinian Intensive Care Society
Sponsor class: OTHER
First posted: 2024-10-28
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (over 17 years of age) who have required intubation and connection to mechanical ventilation due to acute respiratory failure hypoxemia for more than 24 hours, who have overcome a PVE and are ready to be extubated in the Intensive Care Units of the metropolitan area of Buenos Aires (AMBA).

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?


Eligibility criteria: 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

Primary outcomes:
measure: Extubation failure
timeFrame: From enrollment to the end of follow-up at day 7
Secondary outcomes:
measure: Cut-off point of P01
timeFrame: From enrollment to the end of follow-up at day 7
Other outcomes:
Locations:
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Sanatorio Anchorena Recoleta
Study officials:
References:
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