Airway Closure During Extracorporeal Membrane Oxygenation: The AiCLOSE Study

Recruiting

• Conditions: Acute Hypoxemic Respiratory Failure
• Interventions: Other: Acute hypoxemic respiratory failure patients on VV-ECMO

• Registration Number: NCT05196074
• Lead Sponsor: Lorenzo delSorbo

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-15
• Study First Submitted QC: 2022-01-04
• Study First Posted: 2022-01-19
• Study Start: 2022-04-04
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-10
• Primary Completion: 2025-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 299

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acute hypoxemic respiratory failure patients on VV-ECMO	Acute hypoxemic respiratory failure patients on VV-ECMO	-

Primary Outcome Measures

Name	Time	Method
Prevalence of complete airway closure	Day 1 of VV-ECMO cannulation	Prevalence of complete airway closure during day 1 of VV-ECMO support.

Secondary Outcome Measures

Name	Time	Method
Correlation of the degree of mismatch between clinical PEEP and AOP with patient outcomes	Up to 90 days from VV-ECMO cannulation	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
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 the distribution of airway closure within the lung and between the two lungs by EIT.
Correlation of airway closure with patient outcomes	Up to 90 days from VV-ECMO cannulation	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
Assessment of predictors of airway closure	Up to 90 days from VV-ECMO cannulation	Assessment of body mass index and the degree of obesity as predictors of airway closure.

Trial Locations

Locations (1)

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada