Air Leak Detection and Treatment

NCT05854654 | Recruiting

• 1 other identifier: 2023-11357
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Air Leak From Lung

Outcome Measures

Primary Outcomes (1)

• 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.

  48 months

Secondary Outcomes (3)

• Establishing a standardized measure to localize air leaks in a physiological setting.

  48 months

• Quantify and treat air leaks in a physiological setting

  48 months

• Quantify and treat air leaks in a physiological setting

  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. 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.

Diagnostic Test: Air Leaks

Interventions

Air Leaks DIAGNOSTIC_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.

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, Quebec, H2X 0A9, Canada

RECRUITING

Study Officials

• Moishe Liberman, MD

  CHUM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Moishe Liberman, MD

CONTACT

514-890-8000; moishe.liberman@umontreal.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: April 13, 2023
• First Posted: May 11, 2023
• Study Start: May 2, 2023
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)