Digital Versus Analog Pleural Drainage in Patients With Pulmonary Air Leak (DiVA)
The amount of air leaking from a chest tube can be measured in two main ways:
- electronic monitor connected to the chest tube
- 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.
Pulmonary Air Leak
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Digital Versus Analog Pleural Drainage in Patients With Pulmonary Air Leak|
- Inter-rater variability of air leak measurements. [ Time Frame: Post-op ] [ Designated as safety issue: No ]Time frame will occur once patients have experienced an air leak. 70% of patients are expected to have a PAL on postoperative day 1. There will be a 4 hour window to complete observations from the numerical device. These observations will be followed by observations on digital device. Each observer should spend 5-10 min to complete both tasks.
|Study Start Date:||January 2012|
|Study Completion Date:||November 2012|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01566032
|Ottawa General Hospital|
|Ottawa, Ontario, Canada, K1H 8L6|
|Principal Investigator:||Sebastien Gilbert, MD||Ottawa Hospital/Ottawa Hospital Research Institute|