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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05196074
Other study ID # 21-5784
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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