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NCT Number: NCT06662201

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

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?

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Ventilator Weaning Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sanatorio Anchorena Recoleta

Buenos Aires, Buenos Aires F.D., 1425, Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Extubation failure

    Time frame: 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 outcomes

  1. Cut-off point of P01

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Argentinian Intensive Care Society

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 28, 2024
Registry last updated
Oct 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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