Recruiting

Observational Study

Sponsor:

Lorenzo delSorbo

Code:

NCT05196074

Conditions

Acute Hypoxemic Respiratory Failure

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Acute hypoxemic respiratory failure patients on VV-ECMO

Study Details

Brief summary:

About 65,000 Canadians develop acute respiratory failure requiring breathing machines (ventilators) to give oxygen to their lungs. Unfortunately, up to 50% of these individuals will not survive their illness.

Mechanical ventilation through breathing machines, though potentially lifesaving, may further injure the lungs and the respiratory muscles. In the patients with the most severe and life threatening forms of respiratory failure a breathing machine alone may not be able to provide enough oxygen to the lungs and vital organs. In these critical situations, patients may require an artificial lung machine, which is referred to as extracorporeal membrane oxygenation (ECMO) to temporarily replace the function of the patient's own lung and supply critical oxygen to the body, while protecting the damaged lungs. How to use the breathing machine safely while a patient is on ECMO is still unknown. Using conventional breathing machine settings while on ECMO can lead to large portions of the lungs or airway to remain collapsed, which can contribute to further lung damage.

The investigators have recently discovered a way of detecting if patients on a breathing machine suffer from collapsed airways. Knowing if the most severe patients on ECMO have airway collapse is a pivotal question that the investigators plan to answer in our study. The investigators will use our technique to determine how many patients on ECMO have airway closure and determine if this contributes to a longer time on ECMO and a longer time on a breathing machine, and if this impacts a patient's survival in the intensive care unit.

Conditions

Acute Hypoxemic Respiratory Failure

Study ID

NCT05196074

Start date

Apr 4, 2022

Status verified date

May, 2024

Completion date

Apr, 2026

Anticipated

Primary completion date

Apr, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Acute hypoxemic respiratory failure
  • VV-ECMO
  • Less than 24 hours from ECMO cannulation

Exclusion Criteria:

  • Air leak
  • VV-ECMO as bridge to lung transplantation
  • Status asthmaticus

Study Design

Enrollment

299 participants

Anticipated

Interventions and Outcome Measures

Arms

Acute hypoxemic respiratory failure patients on VV-ECMO

Interventions

Acute hypoxemic respiratory failure patients on VV-ECMO

To describe the prevalence of complete airway closure in patients with acute hypoxemic respiratory failure on VV-ECMO and its association with outcome.

Primary outcome measure

  • Prevalence of complete airway closure [ Time Frame: Day 1 of VV-ECMO cannulation ]

Central Contacts and Locations

Central contacts

Hesham Abdelhady, B Pharm

416-340-4800Hesham.Abdelhady@uhn.ca

Locations

Toronto General Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2N2

Contacts

Hesham Abdelhady, B Pharm

416-340-4800Hesham.Abdelhady@uhn.ca

Principal Investigator:

Lorenzo Del Sorbo, MD

More Information

Sponsor

Lorenzo delSorbo

Last update posted

May 10, 2024

Last verified

May, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Lorenzo delSorbo on 2024-05-10.