Digital Versus Analog Pleural Drainage in Patients With Pulmonary Air Leak

Pulmonary Air Leak Clinical Trial

— DiVA  

Official title:

Digital Versus Analog Pleural Drainage in Patients With Pulmonary Air Leak

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01566032
• Other study ID #: 2011619-01H
• Status: Completed
• Phase: N/A
• First received: March 26, 2012
• Last updated: July 5, 2017
• Start date: January 2012
• Est. completion date: November 2012

Study information

• Verified date: July 2017
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or over

• Male and Female.

• Air leak occuring after any pulmonary resection

• Air leak persisting on or after the first post-op day of pleural drainage

• Air leak not entirely secondary to poor air seal at the pleural drainage incision site

• Pulmonary resection for benign or neoplastic diagnosis

Exclusion Criteria:

• Tension pneumothorax

• Traumatic or iatrogenic pneumothorax

• Primary or recurrent spontaneous pneumothorax awaiting surgery

• Pneumonectomy patient (history of or current)

Related Conditions & MeSH terms

• Pulmonary Air Leak

Locations

Country	Name	City	State
Canada	Ottawa General Hospital	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inter-rater variability of air leak measurements.	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.	Post-op