Air Leak From Lung Clinical Trial
— CT0128Official title:
Defining Novel Strategies for the Diagnosis and Treatment of Intraoperative Air Leaks: An Ex-Vivo Human Lung Model Study
NCT number | NCT05854654 |
Other study ID # | 2023-11357 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2, 2023 |
Est. completion date | April 1, 2027 |
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | April 1, 2027 |
Est. primary completion date | April 1, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients undergoing lung transplant surgery - Organ donor ineligible to donate lungs Exclusion Criteria: - Healthy individuals |
Country | Name | City | State |
---|---|---|---|
Canada | CHUM | Montréal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Centre hospitalier de l'Université de Montréal (CHUM) |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | 48 months | |
Secondary | 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) | 48 months | |
Secondary | 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) | 48 months |
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