Airway Closure During Extracorporeal Membrane Oxygenation: The AiCLOSE Study (AiCLOSE)

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Hypoxemic Respiratory Failure
• Intervention / Treatment: Other: Acute hypoxemic respiratory failure patients on VV-ECMO

• Study Type: Observational
• Enrollment (Estimated): 299

Contacts and Locations

• Study Contact: Name: Hesham Abdelhady, B Pharm; Phone Number: 6056 416-340-4800; Email: Hesham.Abdelhady@uhn.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2N2
      • Recruiting
      • Toronto General Hospital
      • Contact: Hesham Abdelhady, B Pharm; Phone Number: 6056 416-340-4800; Email: Hesham.Abdelhady@uhn.ca
      • Principal Investigator: Lorenzo Del Sorbo, MD
      • Sub-Investigator: Niall Ferguson, MD
      • Sub-Investigator: Eddy Fan, MD
      • Sub-Investigator: Ewan Goligher, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Acute hypoxemic respiratory failure patients on VV-ECMO.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Acute hypoxemic respiratory failure patients on VV-ECMO	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of complete airway closure	Prevalence of complete airway closure during day 1 of VV-ECMO support.	Day 1 of VV-ECMO cannulation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of airway closure with patient outcomes	Evaluation of the correlation between the presence of complete airway closure and the level of airway opening pressure and both clinical and physiological outcomes listed below: a. Clinical outcomes i. duration of ECMO support at 90 days ii. duration of mechanical ventilation at 90 days iii. ICU mortality iv. mortality at 90 days v. prevalence of barotrauma vi. daily ECMO support I. sweep gas II. Flow vii. Daily fluid balance b. Physiological outcomes i. time to recovery I. In spontaneous modes of ventilation compliance will be measured by dividing tidal volume by driving pressure ii. time to protective spontaneous breathing (defined as: a. ventilator not continuously triggered by the patient I. Pocc is measured by performing an end-expiratory occlusion maneuver, freezing the ventilator waveform and measuring the drop in airway pressure. iii. lung recruitability iv. right ventricular dysfunction	Up to 90 days from VV-ECMO cannulation
Correlation of the degree of mismatch between clinical PEEP and AOP with patient outcomes	Evaluation of the correlation between the degree of mismatch between clinical PEEP and AOP and patient outcomes listed below: a. Clinical outcomes i. duration of ECMO support at 90 days ii. duration of mechanical ventilation at 90 days iii. ICU mortality iv. mortality at 90 days v. prevalence of barotrauma vi. daily ECMO support I. sweep gas II. Flow vii. Daily fluid balance b. Physiological outcomes i. time to recovery I. In spontaneous modes of ventilation compliance will be measured by dividing tidal volume by driving pressure ii. time to protective spontaneous breathing (defined as: a. ventilator not continuously triggered by the patient I. Pocc is measured by performing an end-expiratory occlusion maneuver, freezing the ventilator waveform and measuring the drop in airway pressure. iii. lung recruitability iv. right ventricular dysfunction	Up to 90 days from VV-ECMO cannulation
Assessment of the distribution of airway closure within the lung and between the two lungs	Assessment of the distribution of airway closure within the lung and between the two lungs by EIT.	Up to 90 days from VV-ECMO cannulation
Assessment of predictors of airway closure	Assessment of body mass index and the degree of obesity as predictors of airway closure.	Up to 90 days from VV-ECMO cannulation

Collaborators and Investigators

• Sponsor: Lorenzo delSorbo
• Collaborators: Unity Health Toronto
• Investigators: Principal Investigator: Lorenzo Del Sorbo, MD, University Health Network, Toronto; Principal Investigator: Michael Sklar, MD, Unity Health Toronto; Principal Investigator: Laurent Brochard, MD, Unity Health Toronto

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2022
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: December 15, 2021
• First Submitted That Met QC Criteria: January 4, 2022
• First Posted (Actual): January 19, 2022

Study Record Updates

• Last Update Posted (Actual): May 10, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 21-5784

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No