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Aerosol Glycerine System for Detecting Lung Air Leaks (CT0136 Trial)

N/A

Recruiting

Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to develop a system to find air leaks in lungs after surgery, reducing postop complications, morbidity & length of stay.

Who is the study for?

This trial is for patients undergoing lung transplant surgery or those who are organ donors but ineligible to donate their lungs. Healthy individuals cannot participate.

What is being tested?

The study is testing a new system that uses aerosol glycerine smoke to detect and localize air leaks during lung surgery, which could improve postoperative outcomes and reduce hospital stays.

What are the potential side effects?

Potential side effects may include irritation from the glycerine smoke or reactions related to its inhalation, although specific side effects will be monitored throughout the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Localization efficacy

Secondary study objectives

Duration of localization

Minimal leak localizable

Staple lines airtightness

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Air LeaksExperimental Treatment1 Intervention

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.

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