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 — 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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Endeavor HealthEvanstonIllinois60201
Kanwal Zeeshan

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