Gas analyzer for chest drains to detect pleural air leaks
Feasibility and Accuracy of a Novel Pleural Drain Gas Analyzer in Detecting Air Leaks
This study will test a small reusable gas analyzer that connects to chest drains to detect air leaks in adults undergoing thoracic surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 33 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Lung Healing Technologies Inc Industry-sponsored |
| Locations | 1 site (Evanston, Illinois) |
| Trial ID | NCT06548386 on ClinicalTrials.gov |
What this trial studies
The device plugs into the sampling port of any analog chest drain and measures carbon dioxide, oxygen, and pressure to identify breath in the drain outlet. Investigators will compare gas-analysis findings to the standard visual inspection of bubbling to distinguish true air leaks from false positives. The protocol enrolls adults expected to receive chest tubes after thoracic surgery and examines how patient factors (extent of resection, lung function, comorbidities) affect device performance. Outcomes include the device's ability to detect changes in exhaled gas flow and its diagnostic accuracy versus visual inspection.
Who should consider this trial
Good fit: Adults (over 18) scheduled for thoracic surgery who are expected to have a chest tube placed and who can provide informed consent (or have a legally authorized representative) are ideal candidates.
Not a fit: People who are hemodynamically unstable, pregnant, incarcerated, under 18, or who will not have an analog chest drain in place are unlikely to benefit from this device.
Why it matters
Potential benefit: If successful, the analyzer could detect air leaks earlier and more accurately, potentially reducing unnecessary chest tube time and speeding recovery.
How similar studies have performed: Earlier pilot testing at Northwestern in 2013 and related publications and patents suggest gas analysis can help diagnose and resolve air leaks, so this builds on promising but limited prior work.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients who are scheduled for thoracic surgery and expected to have chest tube placed 2. For patients who are unable to sign consent, but meet all of the inclusion criteria and none of the exclusion criteria, a legally appointed representative (LAR) will be allowed to sign consent for that patient 3. Patients that provide informed consent for the study 4. Patients \>18 years old Exclusion Criteria: 1. Patients with hemodynamic instability 2. Pregnant patients 3. Prisoners 4. Individuals who are not yet adults
Where this trial is running
Evanston, Illinois
- Endeavor Health — Evanston, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Dan Dodd
- Email: ddodd@lunghealingtechnologies.com
- Phone: 3033242264
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.