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

NCT ID: NCT05971719

Last Updated: 2024-12-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-20
• Study Completion Date: 2027-07-01

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Air Leaks: Aerosol glycerine System

Intervention Type: 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.

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Healthy individuals

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHUM

Montreal, , Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Moishe Liberman, MD

Role: CONTACT

Phone: 514-890-8000

Email: moishe.liberman@umontreal.ca

Adeline Jouquan, MSc

Role: CONTACT

Phone: 514-890-8000

Email: adeline.jouquan.chum@ssss.gouv.qc.ca

Facility Contacts

Moishe Liberman, MD

Role: primary

Other Identifiers

2024-11574

Identifier Type: -

Identifier Source: org_study_id