Feasibility and Accuracy of a Novel Pleural Drain Gas Analyzer in Detecting Air Leaks
Lung Healing Technologies Inc
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.
Description
Tests on patients in 2013 at Northwestern demonstrated that gas analysis can help diagnose and heal air leaks by detecting breath in chest drains, as documented in the investigator's patents and peer-reviewed publications. CO2 is 100 times higher in the lung than ambient, and O2 the same amount lower in ppm. The length of time that it takes to detect breath at the outlet is related to the size of the air leak. O2 is available next to every bed, often used in recovery, and when high O2 is quickly detected at the sampling port, the only source can be an active air leak. The primary aim is to as…
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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
Interventions
- DevicePleural 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.
Location
- Endeavor HealthEvanston, Illinois