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Air Leak Management for Pneumothorax (CT0128 Trial)

N/A

Recruiting

Led By Moishe Liberman, MD

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 tests a method to detect, reduce and treat air leaks during surgery, potentially reducing complications, morbidity and hospital stays for lung surgery.

Who is the study for?

This trial is for patients undergoing lung transplant surgery who cannot donate their lungs. It's not open to healthy individuals.

What is being tested?

The study aims to develop a method to detect, measure, and treat air leaks during surgery using a bio-adhesive. This could reduce complications and hospital stays after lung surgeries.

What are the potential side effects?

Potential side effects may include reactions to the bio-adhesive such as inflammation or infection at the application site, but specific side effects will depend on individual patient responses.

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

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.

Secondary study objectives

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

Quantify and treat air leaks in a physiological setting

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. 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.

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