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

ConditionsAir Leak From Lung Pneumothorax

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorLung Healing Technologies Inc

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

For patients who are unable to sign consent, but meet all of the inclusion criteria and none of the

Disqualifiers

Patients that provide informed consent for the study

Patients >18 years old

Patients with hemodynamic instability

Pregnant patients

Trial design

Design model

Single group

Treatments tested in this trial

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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

Accuracy alone

Whether gas analysis can accurately assess for air leak

Time frame

One year

Secondary outcomes

Using VI as well

Comparison of accuracy in air leak assessment between gas analysis and visual inspection

Time frame

One year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lung Healing Technologies Inc

Lead sponsor

Source ClinicalTrials.gov

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