Feasibility and Accuracy of a Novel Pleural Drain Gas Analyzer in Detecting Air Leaks
Part of paid clinical trials in Evanston, Illinois.
- Sponsor
- Lung Healing Technologies Inc
- Study ID
- NCT06548386
- Status
- Recruiting
Conditions
- Air Leak From Lung
- Pneumothorax
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Pleural gas analysis — DEVICEPatients enrolled in this study will undergo both VI and pleural gas analysis to assess for air leak following surgical chest tube placement. For pleural gas analysis, an outlet gas analyzer will be kept on the outlet port of the chest drain for the entire duration of time that a chest tube is in place. We plan to collect both continuous data, looking for intermittent spikes and gas changes, along with episodic data collected during specific air leak assessments. The gas analyzer may better be able to measure an air leak during these specific procedures conducted twice per day, but it will also be used at the outlet port of the chest drain the rest of the time to continuously check for an air leak throughout the hospital stay.
Study Details
The goal of this study is to assess the clinical feasibility of a novel, reusable, low cost gas analyzer that detects breath in chest drains in order to diagnose and heal air leaks. The investigators have developed prototype gas analyzers that attach to the outlet of any analog chest drain, and can be connected temporarily to the sampling port. They detect breath by measuring CO2, O2, and pressure, in order to supplement the information provided by the bubbles in the water seal.
Key Dates
- Start date
- Feb 5, 2025
- Status verified
- Sep 2025
- Primary completion
- Jan 31, 2026
- Completion
- Jun 30, 2026
Study Design
- Enrollment
- 33 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- DIAGNOSTIC
Primary Outcome Measure
Accuracy alone [ Time Frame: One year ]
Central Contacts
- Dan Dodd3033242264
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Endeavor Health | Evanston | Illinois | 60201 | Kanwal Zeeshan |
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