Clinical trial NCT05196074: Airway Closure During Extracorporeal Membrane Oxygenation: The AiCLOSE Study
Official title: Airway Closure During Extracorporeal Membrane Oxygenation: The AiCLOSE Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Hypoxemic Respiratory Failure
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Unity Health Toronto
First posted: 2022-01-19
Enrollment: 299
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute hypoxemic respiratory failure patients on VV-ECMO.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of complete airway closure
timeFrame: Day 1 of VV-ECMO cannulation
Secondary outcomes:
measure: Correlation of airway closure with patient outcomes
timeFrame: Up to 90 days from VV-ECMO cannulation
measure: Correlation of the degree of mismatch between clinical PEEP and AOP with patient outcomes
timeFrame: Up to 90 days from VV-ECMO cannulation
measure: Assessment of the distribution of airway closure within the lung and between the two lungs
timeFrame: Up to 90 days from VV-ECMO cannulation
measure: Assessment of predictors of airway closure
timeFrame: Up to 90 days from VV-ECMO cannulation
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Lorenzo Del Sorbo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unity Health Toronto
name: Laurent Brochard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unity Health Toronto
name: Michael Sklar, MD
role: PRINCIPAL_INVESTIGATOR
References: