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Clinical Trials in the USA / NCT06548386
Recruiting Not applicable

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

NCT06548386 · tracked via the Priya Life Science USA tracker
Sponsor
Lung Healing Technologies Inc
Phase
Not applicable
Started
2025-02-05
Last updated
2025-09-09

Condition(s) studied

Air Leak From LungPneumothorax

Investigational drug(s) / intervention(s)

Pleural gas analysis

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Endeavor Health Evanston Illinois Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06548386 on ClinicalTrials.gov ↗ ← All trials in the USA