Validation of a System Using Aerosol Glycerine to Detect and Localize Intraoperatively Pulmonary Air Leaks

NCT05971719 | Recruiting

• 1 other identifier: 2024-11574
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  48 months

Secondary Outcomes (3)

• Duration of localization

  48 months

• Minimal leak localizable

  48 months

• Staple lines airtightness

  48 months

Study Arms (1)

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.

Diagnostic Test: Air Leaks: Aerosol glycerine System

Interventions

Air Leaks: Aerosol glycerine System DIAGNOSTIC_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.

Air Leaks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Healthy individuals

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

CHUM

Montreal, H2X 0A9, Canada

RECRUITING

Central Study Contacts

Moishe Liberman, MD

CONTACT

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

Adeline Jouquan, MSc

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: August 2, 2023
• Study Start: July 20, 2023
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

CA (1)