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

October 25, 2024 updated by: Argentinian Intensive Care Society

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?

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

256

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Ciudad Autónoma de Buenos Aires, Argentina, 1425
        • Sanatorio Anchorena Recoleta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Acute respiratory failure
Adult patients (over 17 years of age) who have been intubated for acute respiratory failure hypoxemia for more than 24 hours, who have overcome a spontaneous breathing trial (SBT) and are fit to be extubated in the intensive care unit of the participating centers, who meet the inclusion criteria, who do not have exclusion criteria and from whom informed consent is obtained (from them or their immediate family member).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of follow-up at day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of follow-up at day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Argentinian Intensive Care Society

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 29, 2024

Primary Completion (Estimated)

August 29, 2025

Study Completion (Estimated)

August 29, 2025

Study Registration Dates

First Submitted

October 25, 2024

First Submitted That Met QC Criteria

October 25, 2024

First Posted (Actual)

October 28, 2024

Study Record Updates

Last Update Posted (Actual)

October 28, 2024

Last Update Submitted That Met QC Criteria

October 25, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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