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

Not Applicable

Recruiting

• Conditions: Air Leak From Lung

• Registration Number: NCT05971719
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-07
• Study Start: 2023-07-20
• Study First Submitted QC: 2023-07-25
• Study First Posted: 2023-08-02
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-13
• Primary Completion: 2027-07-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

• Healthy individuals

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Localization efficacy	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.

Secondary Outcome Measures

Name	Time	Method
Staple lines airtightness	48 months	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.
Duration of localization	48 months	Mesure the time required for the surgeon to localize the air leak area by the surgeon. Compare that time to the submertion test localization.
Minimal leak localizable	48 months	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.

Trial Locations

Locations (1)

CHUM; 🇨🇦 Montréal, Canada