Feasibility and Accuracy of a Novel Pleural Drain Gas Analyzer in Detecting Air Leaks

NCT06548386 | Recruiting FDA Device

• 1 other identifier: STUDY00000003
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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

Keywords

alveolopleural fistula

Outcome Measures

Primary Outcomes (1)

• Accuracy alone

  Whether gas analysis can accurately assess for air leak

  One year

Secondary Outcomes (1)

• Using VI as well

  One year

Interventions

Pleural gas analysis DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are scheduled for thoracic surgery and expected to have chest tube placed

You may not qualify if:

• Patients that provide informed consent for the study
• Patients \>18 years old
• Patients with hemodynamic instability
• Pregnant patients
• Prisoners
• Individuals who are not yet adults

Sponsors & Collaborators

• Lung Healing Technologies Inc: lead

Study Sites (1)

Endeavor Health

Evanston, Illinois, 60201, United States

RECRUITING

MeSH Terms

Conditions

Pneumothorax

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Central Study Contacts

Dan Dodd

CONTACT

3033242264; ddodd@lunghealingtechnologies.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 12, 2024
• Study Start: February 5, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)