Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06548386

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

Led by Lung Healing Technologies Inc · Updated on 2025-09-09

33

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a new, reusable, low-cost gas analyzer designed to detect breath in chest drains for diagnosing and healing air leaks after thoracic surgery. This device measures carbon dioxide, oxygen, and pressure to provide additional information beyond the traditional visual inspection of bubbles in water-sealed chest drains. The study aims to determine if this gas analyzer can more accurately identify true air leaks compared to the standard method. Patients in this study will have the gas analyzer attached to the outlet port of their analog chest drain for the entire time the chest tube is in place. The device collects continuous data to detect intermittent spikes and changes in gas levels, and episodic data during specific air leak assessments performed twice daily. The study compares the gas analyzer's performance to the standard visual inspection method in detecting air leaks. Participants will be monitored throughout their hospital stay while the chest tube is in place. The study will assess the accuracy of the gas analyzer in detecting air leaks over one year, with additional evaluation using the standard visual inspection method. Researchers will also consider patient factors like lung function and extent of surgery to understand their impact on the device's effectiveness. Safety and clinical outcomes related to air leaks, pneumothorax, and subcutaneous emphysema will be monitored up to four weeks after chest tube removal.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients who are scheduled for thoracic surgery and expected to have chest tube placed
  • Patients who provide informed consent for the study
  • Patients 18 years old or older
  • Patients unable to sign consent may have a legally appointed representative sign for them
Not Eligible

You will not qualify if you...

  • Patients with hemodynamic instability
  • Pregnant patients
  • Prisoners
  • Individuals who are not yet adults

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Duration of chest tube placement during hospital stay

Participants undergo pleural gas analysis using a gas analyzer device placed on the outlet port of the chest drain following thoracic surgery to detect air leaks. The device continuously monitors gas levels while also capturing data during specific air leak assessments conducted twice daily throughout the hospital stay.

Continuous monitoring with twice daily assessments during hospital stay

Trial Site Locations

Total: 1 location

1

Endeavor Health

Evanston, Illinois, United States, 60201

Actively Recruiting

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Research Team

D

Dan Dodd

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

0

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