Airway Closure During Extracorporeal Membrane Oxygenation: The AiCLOSE Study

Acute Hypoxemic Respiratory Failure Clinical Trial

— AiCLOSE  

Official title:

Airway Closure During Extracorporeal Membrane Oxygenation: The AiCLOSE Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05196074
• Other study ID #: 21-5784
• Status: Recruiting
• Start date: April 4, 2022
• Est. completion date: April 2026

Study information

• Verified date: May 2024
• Source: University Health Network, Toronto
• Contact: Hesham Abdelhady, B Pharm
• Phone: 416-340-4800
• Email: Hesham.Abdelhady[@]uhn.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 299
• Est. completion date: April 2026
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Hypoxemic Respiratory Failure
• Respiratory Insufficiency

Intervention

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.

Locations

Country	Name	City	State
Canada	Toronto General Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lorenzo delSorbo	Unity Health Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of complete airway closure	Prevalence of complete airway closure during day 1 of VV-ECMO support.	Day 1 of VV-ECMO cannulation
Secondary	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
Secondary	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
Secondary	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
Secondary	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