Feasibility and Accuracy of a Novel Pleural Drain Gas Analyzer in Detecting Air Leaks
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Accuracy alone
Study Overview
Brief 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.
Detailed 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 assess whether the device can accurately measure changes in gas flow from an analog pleural drain and whether this accurately detects pleural air leaks.
Specific aim 1: To determine whether the gas analyzer device can measure changes in exhaled gas levels and if this can distinguish true air leaks from false air leaks.
Sub aim 1: Assess how patient characteristics such as extent of resection, pre-existing conditions such as COD, lung function test, etc, affect the efficacy of the device.
Specific aim 2: Compare the accuracy of pleural air leak measured via gas analysis to the accuracy of pleural air leak detection as measured by standard VI.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •, a legally appointed representative (LAR) will be allowed to sign consent for that patient
- •Patients that provide informed consent for the study
- •Patients >18 years old
- •Exclusion Criteria:
- •Patients with hemodynamic instability
- •Pregnant patients
- •Individuals who are not yet adults
Outcomes
Primary Outcomes
Accuracy alone
Time Frame: One year
Whether gas analysis can accurately assess for air leak
Secondary Outcomes
- Using VI as well(One year)