Air Leak From LungCT0136NCT05971719
Validation of a System Using Aerosol Glycerine to Detect and Localize Intraoperatively Pulmonary Air Leaks
A study testing Air Leaks: Aerosol glycerine System in people with Air Leak From Lung, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
Air leaks represent one of the most common complications and postoperative morbidity in thoracic surgery. Air leaks have been associated with the largest preventable morbidity associated with increased costs following lobectomy (typically related to increased length of stay). 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: Aerosol glycerine System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 20 Jul 2023to 1 Jul 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, H2X 0A9
Moishe Liberman, MD, 514-890-8000 ext. 26832, moishe.liberman@umontreal.ca
About this study
Air leaks represent one of the most common complications and postoperative morbidity in thoracic surgery. Air leaks have been associated with the largest preventable morbidity associated with increased costs following lobectomy (typically related to increased length of stay). However, the standard used to detect and localize the air leaks, the submersion test, is not suitable for the standard surgical procedure, Video Assisted Thoracic Surgery. Considering the prevalence of this complication and the absence of a surgical standard of care for such complications, the aim of this study is to develop a system to create and send a glycerine aerosol smoke in the lungs of the patient. The smoke is visible with standard laparoscope and will flow though the pulmonary leak, thereby reducing postoperative surgical complications, morbidity, and length of stay for patients undergoing pulmonary resection.
- Conditions
- Air Leak From Lung
- Being tested
- Air Leaks: Aerosol glycerine System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air Leaks: Aerosol glycerine SystemDiagnostic test
A range of different leak will be done with different needle sizes on the lung. Perform localization on staple lines used surgically during pulmonary surgeries, as they are known to not consistently give an airtight closure. The lung will be put in the ex-vivo model and ask for a surgeon to localize the leaks with our system. The needle incisions will be repeat on another lung and ask the same surgeon to localize the leaks with the submersion test. To perform the submersion test the surgeon will have to submerge the lung in saline solution and to check the presence of air bubbles. The lung is inflated to pressures of 20 to 40 cm H209. The precision of both systems will be compared by the minimal incision the minimal incision the surgeon was able to localize.
| 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. To establish a standard protocol to use our system we will use a dark box to validate that our system is able to localize the air leaks and to establish the best way to use the system. A one centimeter leak will be created on the lung with a scalpel. A laparoscope will be introduced via a trocar in the dark box and the surgeon will be asked to localize the leaks. The detection will be recorded via the laparoscope. The goal will be to perform a standardized protocol to use the system smoothly and efficiently on ex-vivo human lungs. Receives: Diagnostic Test: Air Leaks: Aerosol glycerine System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Localization efficacy
Puncture the lungs to achieve an average size air leak (1-2 cm) and ask the surgeon to identify the airleak with the localization system. Register a success if the surgeon has properly localized the air leak and a failure if the surgeon has failed to localize the air leak. Destinguish the failures in false positive (Air leak detected in a non leaking area of the lung) and false negative (Air leak not detected when present). Compare that efficacy rate to the efficacy of a similar experiement done with the submersion technique.
Measured: 48 months
Secondary outcomes (3)
Duration of localization
Mesure the time required for the surgeon to localize the air leak area by the surgeon. Compare that time to the submertion test localization.
Measured: 48 months
Minimal leak localizable
Puncture the lungs with different needle sizes and ask a surgeon to localize the air leaks on the lung. Record the smallest hole the surgeon was able to localize with our system. Then, compare the minimal leak localizable with our system to the minimal leak localizable with the submersion test.
Measured: 48 months
Staple lines airtightness
Staple lines are known to not consistently give an airtight closure. But the manufacturers of those staple lines do not know why they are failing. Prove that the system can detect if the staple line is airtight or not, which could be useful for those manufacturers as well as for the clinicians. As leaks won't be created on every staple line, confirm that there is a leak by creating bubbles with saline at the staple line on the ex-vivo lung. Ask a surgeon to give the outcome of the airtightness of the staple line (success or failure) and then, compare the outcome to what we obtained with the localisation system.
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 posted2 Aug 2023
- Study start20 Jul 2023
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 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.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- 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
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05971719
- Sponsor's protocol ID
- 2024-11574
- Acronym
- CT0136
- Status last verified
- Mar 2026
- First submitted
- 7 Jul 2023
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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
- Validation of a System Using Aerosol Glycerine to Detect and Localize Intraoperatively Pulmonary Air Leaks
- ClinicalTrials.gov ID
- NCT05971719
- Acronym / sponsor ID
- CT0136 / 2024-11574
- 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
- 20 Jul 2023 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 2 Aug 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.
Air leaks represent one of the most common complications and postoperative morbidity in thoracic surgery. Air leaks have been associated with the largest preventable morbidity associated with increased costs following lobectomy (typically related to increased length of stay). However, the standard used to detect and localize the air leaks, the submersion test, is not suitable for the standard surgical procedure, Video Assisted Thoracic Surgery. Considering the prevalence of this complication and the absence of a surgical standard of care for such complications, the aim of this study is to develop a system to create and send a glycerine aerosol smoke in the lungs of the patient. The smoke is visible with standard laparoscope and will flow though the pulmonary leak, thereby reducing postoperative surgical complications, morbidity, and length of stay for patients undergoing pulmonary resection.
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 Leaks: Aerosol glycerine SystemLungs from patients undergoing lung transplantation after their removal from the recipient patient with previous informed consent signed before transplantation will be obtained. To establish a standard protocol to use our system we will use a dark box to validate that our system is able to localize the air leaks and to establish the best way to use the system. A one centimeter leak will be created on the lung with a scalpel. A laparoscope will be introduced via a trocar in the dark box and the surgeon will be asked to localize the leaks. The detection will be recorded via the laparoscope. The goal will be to perform a standardized protocol to use the system smoothly and efficiently on ex-vivo human lungs. |
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 Leaks: Aerosol glycerine SystemA range of different leak will be done with different needle sizes on the lung. Perform localization on staple lines used surgically during pulmonary surgeries, as they are known to not consistently give an airtight closure. The lung will be put in the ex-vivo model and ask for a surgeon to localize the leaks with our system. The needle incisions will be repeat on another lung and ask the same surgeon to localize the leaks with the submersion test. To perform the submersion test the surgeon will have to submerge the lung in saline solution and to check the presence of air bubbles. The lung is inflated to pressures of 20 to 40 cm H209. The precision of both systems will be compared by the minimal incision the minimal incision the surgeon was able to localize. | Diagnostic test | Air Leaks |
Primary outcome
Localization efficacy
Time frame: 48 months
Puncture the lungs to achieve an average size air leak (1-2 cm) and ask the surgeon to identify the airleak with the localization system. Register a success if the surgeon has properly localized the air leak and a failure if the surgeon has failed to localize the air leak. Destinguish the failures in false positive (Air leak detected in a non leaking area of the lung) and false negative (Air leak not detected when present). Compare that efficacy rate to the efficacy of a similar experiement done with the submersion technique.
3 secondary outcomes
Duration of localization
Time frame: 48 months
Minimal leak localizable
Time frame: 48 months
Staple lines airtightness
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.
Related trials for Air Leak From Lung
RecruitingObservational study
Prospective Study Evaluating the Effectiveness of Intraoperative Ventilation for Predicting Postoperative Air Leaks During Major Lung Resections by Conventional or Robotic Thoracoscopy
Air Leak From Lung, Lung Surgery
Recruiting
Air Leak Detection and Treatment
Air Leak From Lung
Recruiting
Feasibility and Accuracy of a Novel Pleural Drain Gas Analyzer in Detecting Air Leaks
Air Leak From Lung, Pneumothorax
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.
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: Aerosol glycerine System 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?
Localization efficacy (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.