Airway Closure During Extracorporeal Membrane Oxygenation: The AiCLOSE Study

NCT05196074 | Recruiting

• 1 other identifier: 21-5784
• Study Type: observational
• Target: 299
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Prevalence of complete airway closure

  Prevalence of complete airway closure during day 1 of VV-ECMO support.

  Day 1 of VV-ECMO cannulation

Secondary Outcomes (4)

• Correlation of airway closure with patient outcomes

  Up to 90 days from VV-ECMO cannulation

• Correlation of the degree of mismatch between clinical PEEP and AOP with patient outcomes

  Up to 90 days from VV-ECMO cannulation

• Assessment of the distribution of airway closure within the lung and between the two lungs

  Up to 90 days from VV-ECMO cannulation

• Assessment of predictors of airway closure

  Up to 90 days from VV-ECMO cannulation

Study Arms (1)

Acute hypoxemic respiratory failure patients on VV-ECMO

Other: Acute hypoxemic respiratory failure patients on VV-ECMO

Interventions

Acute hypoxemic respiratory failure patients on VV-ECMO OTHER

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

Acute hypoxemic respiratory failure patients on VV-ECMO

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Acute hypoxemic respiratory failure patients on VV-ECMO.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Lorenzo delSorbo: lead
• Unity Health Toronto: collaborator

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2N2, Canada

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Lorenzo Del Sorbo, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

• Laurent Brochard, MD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

• Michael Sklar, MD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hesham Abdelhady, B Pharm

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, Critical Care Medicine Department, Toronto General Hospital

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: January 19, 2022
• Study Start: April 4, 2022
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2026
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)