Acute Hypoxemic Respiratory FailureAiCLOSENCT05196074
Airway Closure During Extracorporeal Membrane Oxygenation: The AiCLOSE Study
An observational study of Acute Hypoxemic Respiratory Failure, run by Lorenzo delSorbo at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Hypoxemic Respiratory Failure
- What is being tested?
- Acute hypoxemic respiratory failure patients on VV-ECMO
- How many people
- 299 participants
- Where
- 1 siteCanada
- Study dates
- 4 Apr 2022to Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Acute hypoxemic respiratory failure patients on VV-ECMO.
Who may be able to join
- Acute hypoxemic respiratory failure
- VV-ECMO
- Less than 24 hours from ECMO cannulation
Who cannot join
- Air leak
- VV-ECMO as bridge to lung transplantation
- Status asthmaticus
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Toronto General Hospital
Toronto, Ontario, M5G 2N2
Hesham Abdelhady, B Pharm, 416-340-4800 ext. 6056, Hesham.Abdelhady@uhn.ca
Lorenzo Del Sorbo, MD
About this study
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.
- Conditions
- Acute Hypoxemic Respiratory Failure
- Being tested
- Acute hypoxemic respiratory failure patients on VV-ECMO
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute hypoxemic respiratory failure patients on VV-ECMOOther
To describe the prevalence of complete airway closure in patients with acute hypoxemic respiratory failure on VV-ECMO and its association with outcome.
| Study group | Role | What they receive |
|---|---|---|
| Acute hypoxemic respiratory failure patients on VV-ECMO | Not described Receives: Other: Acute hypoxemic respiratory failure patients on VV-ECMO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of complete airway closure
Prevalence of complete airway closure during day 1 of VV-ECMO support.
Measured: Day 1 of VV-ECMO cannulation
Secondary outcomes (4)
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:
- 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
Measured: 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:
- 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
Measured: 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.
Measured: 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.
Measured: Up to 90 days from VV-ECMO cannulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start4 Apr 2022
- Primary completionApr 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Hypoxemic Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 299 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lorenzo delSorbo
- Sponsor type
- University, hospital or other
- Collaborators
- Unity Health Toronto
- Responsible party
- Sponsor-investigator, Lorenzo delSorbo, University Health Network, Toronto
- Investigators
- Lorenzo Del Sorbo, MD, Principal investigator, University Health Network, TorontoLaurent Brochard, MD, Principal investigator, Unity Health TorontoMichael Sklar, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05196074
- Sponsor's protocol ID
- 21-5784
- Acronym
- AiCLOSE
- Status last verified
- May 2024
- First submitted
- 15 Dec 2021
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airway Closure During Extracorporeal Membrane Oxygenation: The AiCLOSE Study
- ClinicalTrials.gov ID
- NCT05196074
- Acronym / sponsor ID
- AiCLOSE / 21-5784
- Conditions
- Acute Hypoxemic Respiratory Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 299 participants (estimated)
- Lead sponsor
- Lorenzo delSorboUniversity, hospital or other
- Collaborators
- Unity Health Toronto
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute hypoxemic respiratory failure patients on VV-ECMO | – | Other: Acute hypoxemic respiratory failure patients on VV-ECMO |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Acute hypoxemic respiratory failure patients on VV-ECMO.
Key inclusion criteria (3 listed)
- Acute hypoxemic respiratory failure
- VV-ECMO
- Less than 24 hours from ECMO cannulation
Key exclusion criteria (3 listed)
- Air leak
- VV-ECMO as bridge to lung transplantation
- Status asthmaticus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acute hypoxemic respiratory failure patients on VV-ECMOTo describe the prevalence of complete airway closure in patients with acute hypoxemic respiratory failure on VV-ECMO and its association with outcome. | Other | Acute hypoxemic respiratory failure patients on VV-ECMO |
Primary outcome
Prevalence of complete airway closure
Time frame: Day 1 of VV-ECMO cannulation
Prevalence of complete airway closure during day 1 of VV-ECMO support.
4 secondary outcomes
Correlation of airway closure with patient outcomes
Time frame: Up to 90 days from VV-ECMO cannulation
Correlation of the degree of mismatch between clinical PEEP and AOP with patient outcomes
Time frame: Up to 90 days from VV-ECMO cannulation
Assessment of the distribution of airway closure within the lung and between the two lungs
Time frame: Up to 90 days from VV-ECMO cannulation
Assessment of predictors of airway closure
Time frame: Up to 90 days from VV-ECMO cannulation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorenzo Del Sorbo, MD principal investigator
University Health Network, Toronto
Laurent Brochard, MD principal investigator
Unity Health Toronto
Michael Sklar, MD principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Hypoxemic Respiratory Failure, run by Lorenzo delSorbo at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hesham Abdelhady, B Pharm (416-340-4800 ext. 6056, Hesham.Abdelhady@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of complete airway closure (time frame: Day 1 of VV-ECMO cannulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.