Health TrialsbyHealthPanel

Air Leak Detection and Treatment

ConditionAir Leak From Lung
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre hospitalier de l'Université de Montréal (CHUM)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients undergoing lung transplant surgery

Organ donor ineligible to donate lungs

Disqualifiers

Healthy individuals

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Air LeaksExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
48 months

Secondary outcomes

1

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

Based on preliminary findings, a standardized methodology for the localization will be established

Time frame
48 months
2

Quantify and treat air leaks in a physiological setting

Time to seal air leaks Quantity of air leaks Seal percentage change in output of leak (measured in mL/min)

Time frame
48 months
3

Quantify and treat air leaks in a physiological setting

Comparison in effectiveness of varying sealing technologies Optimal methods for application of sealant Sealant loss (% of total applied)

Time frame
48 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre hospitalier de l'Université de Montréal (CHUM)

Lead sponsor

Source ClinicalTrials.gov
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