Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06548386
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
Feasibility and Accuracy of a Novel Pleural Drain Gas Analyzer in Detecting Air Leaks
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Feasibility and Accuracy of a Novel Pleural Drain Gas Analyzer in Detecting Air Leaks
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 investigators 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
The hypothesis is that the prototype pleural gas analyzer through detection of carbon dioxide and oxygen levels can distinguish true air leaks from false air leaks more accurately than the traditionally practiced method of Visual Inspection of bubbles in the chest drainage unit VI
Study Endpoints
The primary end point of this study is detection of air leak either by VI or prototype pleural gas analysis
True Air Leak Definition
1 Both visual inspection and pleural gas analysis demonstrate an air leak
2 Development of a pneumothorax at any point up to 4 weeks after chest tube removal
3 Pneumothorax develops during a clamp trial to assess for true air leak failed clamp trial
4 Patient discharged home with chest tube due to clinical concern even in absence of clamp trial of ongoing air leak
5 Development of clinically significant subcutaneous emphysema either with a chest tube in place or after chest tube removal defined as an increase beyond initial post op observable to patient or care team Secondary endpoint is comparison in accuracy in detection of air leak between VI and gas analysis
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
The hypothesis is that the prototype pleural gas analyzer through detection of carbon dioxide and oxygen levels can distinguish true air leaks from false air leaks more accurately than the traditionally practiced method of Visual Inspection of bubbles in the chest drainage unit VI
Study Endpoints
The primary end point of this study is detection of air leak either by VI or prototype pleural gas analysis
True Air Leak Definition
1 Both visual inspection and pleural gas analysis demonstrate an air leak
2 Development of a pneumothorax at any point up to 4 weeks after chest tube removal
3 Pneumothorax develops during a clamp trial to assess for true air leak failed clamp trial
4 Patient discharged home with chest tube due to clinical concern even in absence of clamp trial of ongoing air leak
5 Development of clinically significant subcutaneous emphysema either with a chest tube in place or after chest tube removal defined as an increase beyond initial post op observable to patient or care team Secondary endpoint is comparison in accuracy in detection of air leak between VI and gas analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None