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:

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary 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 Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • Ottawa General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

A target of 30 patients at the Ottawa Hospital who experienced pulmonary air leak following pulmonary resection will be recruited.

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Investigators: Principal Investigator: Sebastien Gilbert, MD, Ottawa Hospital/Ottawa Hospital Research Institute

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: March 26, 2012
• First Submitted That Met QC Criteria: March 28, 2012
• First Posted (Estimate): March 29, 2012

Study Record Updates

• Last Update Posted (Actual): July 7, 2017
• Last Update Submitted That Met QC Criteria: July 5, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: digital; pulmonary air leak; Thopaz; analog
• Other Study ID Numbers: 2011619-01H