Airway Closure During Extracorporeal Membrane Oxygenation: The AiCLOSE Study

NCT ID: NCT05196074

Last Updated: 2024-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

299 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-04

Study Completion Date

2026-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Hypoxemic Respiratory Failure

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Acute hypoxemic respiratory failure patients on VV-ECMO

Acute hypoxemic respiratory failure patients on VV-ECMO

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Unity Health Toronto

OTHER

Sponsor Role collaborator

Lorenzo delSorbo

OTHER

Sponsor Role lead

Responsible Party

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Lorenzo delSorbo

MD, Critical Care Medicine Department, Toronto General Hospital

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Lorenzo Del Sorbo, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Laurent Brochard, MD

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Michael Sklar, MD

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Locations

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Toronto General Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Hesham Abdelhady, B Pharm

Role: CONTACT

416-340-4800 ext. 6056

Facility Contacts

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Hesham Abdelhady, B Pharm

Role: primary

416-340-4800 ext. 6056

Other Identifiers

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21-5784

Identifier Type: -

Identifier Source: org_study_id

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