Air Leak From LungCT0128NCT05854654
Air Leak Detection and Treatment
A study testing Air Leaks in people with Air Leak From Lung, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
Developing a methodology to detect, quantify and treat air leaks intraoperatively using a bio-adhesive, to thereby reduce postoperative surgical complications, morbidity, and length of stay for patients undergoing pulmonary resection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Air Leak From Lung
- What is being tested?
- Air Leaks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 2 May 2023to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing lung transplant surgery
- Organ donor ineligible to donate lungs
Who cannot join
- Healthy individuals
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
CHUM
Montreal, Quebec, H2X 0A9
Moishe Liberman, MD, 514-890-8000 ext. 26832, moishe.liberman@umontreal.ca
About this study
Official title: Defining Novel Strategies for the Diagnosis and Treatment of Intraoperative Air Leaks: An Ex-Vivo Human Lung Model Study
Developing a methodology to detect, quantify and treat air leaks intraoperatively using a bio-adhesive, to thereby reduce postoperative surgical complications, morbidity, and length of stay for patients undergoing pulmonary resection.
Read the detailed description
This study aims at establishing a standardized, stable and effective ex-vivo human lung model, applying some changes to settings used in our previous studies both in animal and human models performed in this institution. Multiple procedures will be performed to each model in order to accomplish the objectives of the study. Tissue samples will be taken from the models and images will be performed. This will allow us to determine which configuration is the optimal for obtaining the more effective and stable models that could offer the best quality specimens as well. Lungs from patients undergoing lung transplantation after their removal from the recipient patient with previous informed consent signed before transplantation will be obtained. The organs will be placed in an acrylic box and will be kept at a temperature of 37 Celsius degrees. The lungs will be mechanically ventilated connected by an endotracheal tube size 8 inserted in the bronchus with the balloon inflated and a silk suture providing an hermetic closure proximal to the balloon. Alternatively, and as performed in one of our previous studies, according to the bronchial stump length and diameter, a Penrose drain (1 inch) will be sewn to the mainstem bronchus to simulate the trachea and allow for an endotracheal tube (ET), size 9.0 Fr, to be inserted into and secured with the Penrose drain. Following, a Sheridan® Sher-I-SWIV/FO ™ Double Swivel Connector will be inserted to the tube to allow performing endoscopic and RAB procedures while maintaining ventilation. The mechanical ventilator will be set using positive pressure and high tidal volume to prevent the lungs from collapsing.
A cannula will be placed in the pulmonary artery and secured with a purse-string suture. The lung will be perfused with 37°C solution using a roller pump (Terumo Sarns, Tokyo, Japan) with a flow rate (usually ~0.2 L/min) was adjusted to maintain a pulmonary arterial pressure of 10-12 mmHg to prevent hydrostatic pulmonary edema. The pulmonary veins will not be cannulated, allowing the perfusate to drain passively from the pulmonary veins into the reservoir at the base of the acrylic chamber from where it will be recycled through the pump. Temperatures of the lung tissue, ambient, container, and intravascular will be monitored by thermocouples. The pulmonary arterial pressure will be measured via a pulmonary arterial catheter (Cook, Bloomington, IN) placed in the circuit at the level of the left atrium. Once the model reaches a stable temperature 36°C, the procedures will begin.
This setting will allow us to perform several different endoscopic and RAB procedures in emulated physiologic conditions to complete the study.
In order to reproduce intraoperative air leaks, various manipulations, including stapling and creating lacerations of different depts and lengths on the parenchyma, will be performed on deflated lungs. Following the introduction of a leak, condensed gas will be pushed through the airway to precisely localize the defect. The sealant prepared at room temperature will then be applied in a thin layer to cover the defect and will be left to dry for 5 minutes. The seal will be tested using the condensed gas with the lung still deflated as well as with the water immersion technique after inflating the lung.
The leaks will be quantified using the Thopaz automated drainage system by Medela.
In order to test the long term stability of the matrix, the lung will be ventilated for X minutes. Air leak testing will be repeated at specific intervals during this time.
After all the procedures are finished and specimens obtained, all the lungs will be sent to the CHUM and will be processed following the standard hospital protocol for transplants recipients.
- Conditions
- Air Leak From Lung
- Being tested
- Air Leaks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air LeaksDiagnostic test
The organs will be placed in an acrylic box and will be kept at a temperature of 37 Celsius degrees. The lungs will be mechanically ventilated connected by an endotracheal tube size 8 inserted in the bronchus with the balloon inflated and a silk suture providing an hermetic closure proximal to the balloon.
This setting will allow us to perform several different endoscopic and RAB procedures in emulated physiologic conditions to complete the study.
| Study group | Role | What they receive |
|---|---|---|
| Air Leaks | Experimental | Lungs from patients undergoing lung transplantation after their removal from the recipient patient with previous informed consent signed before transplantation will be obtained. The organs will be placed in an acrylic box and will be kept at a temperature of 37 Celsius degrees. In order to reproduce intraoperative air leaks, various manipulations, including stapling and creating lacerations of different depts and lengths on the parenchyma, will be performed on deflated lungs. Following the introduction of a leak, condensed gas will be pushed through the airway to precisely localize the defect. The sealant prepared at room temperature will then be applied in a thin layer to cover the defect and will be left to dry for 5 minutes. The seal will be tested using the condensed gas with the lung still deflated as well as with the water immersion technique after inflating the lung. Receives: Diagnostic Test: Air Leaks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection and localisation of air leaks in deflated lungs using condensed air through the airway. Changing the size (ml) of air leaks by 80% by the use of a novel bio sealant directly on the lung parenchyma.
The evaluation of different techniques for the detection and localisation of air leaks in deflated lungs.
The application of the novel bio sealant on staple lines or localized lacerations on the lung parenchyma from instrumentation or other will result in a change in the volume (ml) of air leaks.
Measured: 48 months
Secondary outcomes (3)
Establishing a standardized measure to localize air leaks in a physiological setting.
Based on preliminary findings, a standardized methodology for the localization will be established
Measured: 48 months
Quantify and treat air leaks in a physiological setting
Time to seal air leaks Quantity of air leaks Seal percentage change in output of leak (measured in mL/min)
Measured: 48 months
Quantify and treat air leaks in a physiological setting
Comparison in effectiveness of varying sealing technologies Optimal methods for application of sealant Sealant loss (% of total applied)
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start2 May 2023
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Air Leak From LungStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moishe Liberman, MD, Principal investigator, CHUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05854654
- Sponsor's protocol ID
- 2023-11357
- Other IDs
- 2023
- Acronym
- CT0128
- Status last verified
- Mar 2026
- First submitted
- 13 Apr 2023
- Last updated
- 18 Mar 2026
- 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 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining Novel Strategies for the Diagnosis and Treatment of Intraoperative Air Leaks: An Ex-Vivo Human Lung Model Study
- ClinicalTrials.gov ID
- NCT05854654
- Acronym / sponsor ID
- CT0128 / 2023-11357
- Conditions
- Air Leak From Lung
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 2 May 2023 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 11 May 2023 (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.
Developing a methodology to detect, quantify and treat air leaks intraoperatively using a bio-adhesive, to thereby reduce postoperative surgical complications, morbidity, and length of stay for patients undergoing pulmonary resection.
Detailed description
This study aims at establishing a standardized, stable and effective ex-vivo human lung model, applying some changes to settings used in our previous studies both in animal and human models performed in this institution. Multiple procedures will be performed to each model in order to accomplish the objectives of the study. Tissue samples will be taken from the models and images will be performed. This will allow us to determine which configuration is the optimal for obtaining the more effective and stable models that could offer the best quality specimens as well. Lungs from patients undergoing lung transplantation after their removal from the recipient patient with previous informed consent signed before transplantation will be obtained. The organs will be placed in an acrylic box and will be kept at a temperature of 37 Celsius degrees. The lungs will be mechanically ventilated connected by an endotracheal tube size 8 inserted in the bronchus with the balloon inflated and a silk suture providing an hermetic closure proximal to the balloon. Alternatively, and as performed in one of our previous studies, according to the bronchial stump length and diameter, a Penrose drain (1 inch) will be sewn to the mainstem bronchus to simulate the trachea and allow for an endotracheal tube (ET), size 9.0 Fr, to be inserted into and secured with the Penrose drain. Following, a Sheridan® Sher-I-SWIV/FO ™ Double Swivel Connector will be inserted to the tube to allow performing endoscopic and RAB procedures while maintaining ventilation. The mechanical ventilator will be set using positive pressure and high tidal volume to prevent the lungs from collapsing.
A cannula will be placed in the pulmonary artery and secured with a purse-string suture. The lung will be perfused with 37°C solution using a roller pump (Terumo Sarns, Tokyo, Japan) with a flow rate (usually ~0.2 L/min) was adjusted to maintain a pulmonary arterial pressure of 10-12 mmHg to prevent hydrostatic pulmonary edema. The pulmonary veins will not be cannulated, allowing the perfusate to drain passively from the pulmonary veins into the reservoir at the base of the acrylic chamber from where it will be recycled through the pump. Temperatures of the lung tissue, ambient, container, and intravascular will be monitored by thermocouples. The pulmonary arterial pressure will be measured via a pulmonary arterial catheter (Cook, Bloomington, IN) placed in the circuit at the level of the left atrium. Once the model reaches a stable temperature 36°C, the procedures will begin.
This setting will allow us to perform several different endoscopic and RAB procedures in emulated physiologic conditions to complete the study.
In order to reproduce intraoperative air leaks, various manipulations, including stapling and creating lacerations of different depts and lengths on the parenchyma, will be performed on deflated lungs. Following the introduction of a leak, condensed gas will be pushed through the airway to precisely localize the defect. The sealant prepared at room temperature will then be applied in a thin layer to cover the defect and will be left to dry for 5 minutes. The seal will be tested using the condensed gas with the lung still deflated as well as with the water immersion technique after inflating the lung.
The leaks will be quantified using the Thopaz automated drainage system by Medela.
In order to test the long term stability of the matrix, the lung will be ventilated for X minutes. Air leak testing will be repeated at specific intervals during this time.
After all the procedures are finished and specimens obtained, all the lungs will be sent to the CHUM and will be processed following the standard hospital protocol for transplants recipients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Air Leaks | Experimental | Diagnostic Test: Air LeaksLungs from patients undergoing lung transplantation after their removal from the recipient patient with previous informed consent signed before transplantation will be obtained. The organs will be placed in an acrylic box and will be kept at a temperature of 37 Celsius degrees. In order to reproduce intraoperative air leaks, various manipulations, including stapling and creating lacerations of different depts and lengths on the parenchyma, will be performed on deflated lungs. Following the introduction of a leak, condensed gas will be pushed through the airway to precisely localize the defect. The sealant prepared at room temperature will then be applied in a thin layer to cover the defect and will be left to dry for 5 minutes. The seal will be tested using the condensed gas with the lung still deflated as well as with the water immersion technique after inflating the lung. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing lung transplant surgery
- Organ donor ineligible to donate lungs
Key exclusion criteria (1 listed)
- Healthy individuals
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 |
|---|---|---|
| Air LeaksThe organs will be placed in an acrylic box and will be kept at a temperature of 37 Celsius degrees. The lungs will be mechanically ventilated connected by an endotracheal tube size 8 inserted in the bronchus with the balloon inflated and a silk suture providing an hermetic closure proximal to the balloon. This setting will allow us to perform several different endoscopic and RAB procedures in emulated physiologic conditions to complete the study. | Diagnostic test | Air Leaks |
Primary outcome
Detection and localisation of air leaks in deflated lungs using condensed air through the airway. Changing the size (ml) of air leaks by 80% by the use of a novel bio sealant directly on the lung parenchyma.
Time frame: 48 months
The evaluation of different techniques for the detection and localisation of air leaks in deflated lungs. The application of the novel bio sealant on staple lines or localized lacerations on the lung parenchyma from instrumentation or other will result in a change in the volume (ml) of air leaks.
3 secondary outcomes
Establishing a standardized measure to localize air leaks in a physiological setting.
Time frame: 48 months
Quantify and treat air leaks in a physiological setting
Time frame: 48 months
Quantify and treat air leaks in a physiological setting
Time frame: 48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No
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Validation of a System Using Aerosol Glycerine to Detect and Localize Intraoperatively Pulmonary Air Leaks
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Feasibility and Accuracy of a Novel Pleural Drain Gas Analyzer in Detecting Air Leaks
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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.
Moishe Liberman, MD principal investigator
CHUM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Air Leaks in people with Air Leak From Lung, run by Centre hospitalier de l'Université de Montréal (CHUM) 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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 18 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Moishe Liberman, MD (514-890-8000 ext. 26832, moishe.liberman@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection and localisation of air leaks in deflated lungs using condensed air through the airway. Changing the size (ml) of air leaks by 80% by the use of a novel bio sealant directly on the lung parenchyma. (time frame: 48 months). 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 18 Mar 2026.