Recruiting

Pulmonary Air Leaks

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT05971719

Conditions

Air Leak From Lung

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Air Leaks: Aerosol glycerine System

Study Details

Brief 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). 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

Study ID

NCT05971719

Start date

Jul 20, 2023

Status verified date

Mar, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients undergoing lung transplant surgery
  • Organ donor ineligible to donate lungs

Exclusion Criteria:

  • Healthy individuals

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Air Leaks

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.

Interventions

Air Leaks: Aerosol glycerine System

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.

Primary outcome measure

  • Localization efficacy [ Time Frame: 48 months ]

Central Contacts and Locations

Central contacts

Moishe Liberman, MD

514-890-8000moishe.liberman@umontreal.ca

Adeline Jouquan, MSc

514-890-8000adeline.jouquan.chum@ssss.gouv.qc.ca

Locations

CHUM

Recruiting

Montreal, Canada, H2X 0A9

Contacts

Moishe Liberman, MD

514-890-8000moishe.liberman@umontreal.ca

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Mar 18, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2026-03-18.