Recruiting

Gas Analyzer

Sponsor:

Lung Healing Technologies Inc

Code:

NCT06548386

Conditions

Air Leak From Lung

Pneumothorax

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pleural gas analysis

Study Details

Brief summary:

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.

Conditions

Air Leak From Lung

Pneumothorax

Study ID

NCT06548386

Start date

Feb 5, 2025

Status verified date

Sep, 2025

Completion date

Jun, 2026

Anticipated

Primary completion date

Jan, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

33 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Interventions

Pleural gas analysis

Patients 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.

Primary outcome measure

  • Accuracy alone [ Time Frame: One year ]

Central Contacts and Locations

Central contacts

Dan Dodd

3033242264ddodd@lunghealingtechnologies.com

Locations

Endeavor Health

Recruiting

Evanston, Illinois, United States, 60201

More Information

Sponsor

Lung Healing Technologies Inc

Last update posted

Sep 9, 2025

Last verified

Sep, 2025

Keywords

  • alveolopleural fistula

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Lung Healing Technologies Inc on 2025-09-09.