Ignite Creation Date:
2025-12-24 @ 9:29 PM
Ignite Modification Date:
2025-12-25 @ 7:14 PM
Study NCT ID:
NCT01566032
Status:
COMPLETED
Last Update Posted:
2017-07-07
First Post:
2012-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Digital Versus Analog Pleural Drainage in Patients With Pulmonary Air Leak
Sponsor:
Ottawa Hospital Research Institute
Organization:
Study Overview
Official Title:
Digital Versus Analog Pleural Drainage in Patients With Pulmonary Air Leak
Status:
COMPLETED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DiVA
Brief Summary:
The amount of air leaking from a chest tube can be measured in two main ways:
1. electronic monitor connected to the chest tube
2. numerical (non-electronic) monitor connected to the chest tube
For people who have had lung surgery, it is important to understand the impact of measuring air leaks accurately in both the short term and the long term. An electronic medical device called Thopaz measures air leak electronically. Another medical device called Pleur-evac measures air leak numerically. The purpose of this study is to understand the accuracy of the method used by doctors and nurses to determine if a chest tube has an air leak. It is also important to determine the size or severity of an air leak.
1. electronic monitor connected to the chest tube
2. numerical (non-electronic) monitor connected to the chest tube
For people who have had lung surgery, it is important to understand the impact of measuring air leaks accurately in both the short term and the long term. An electronic medical device called Thopaz measures air leak electronically. Another medical device called Pleur-evac measures air leak numerically. The purpose of this study is to understand the accuracy of the method used by doctors and nurses to determine if a chest tube has an air leak. It is also important to determine the size or severity of an air leak.
Detailed Description:
Patients with air leaks following lung surgery will be assessed by a target number of 6 observers each (three nurses and three MDs) who will be randomly asked to participate. Patients will first be connected to the numerical air leak detector, followed by the electronic air leak detector. Observers will record their responses for each device. They will be blinded to responses from other observers.
Study Oversight
Has Oversight DMC:
False
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?: