Digital Versus Analog Pleural Drainage in Patients With Pulmonary Air Leak (DiVA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01566032
Recruitment Status : Completed
First Posted : March 29, 2012
Last Update Posted : July 7, 2017
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

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.

Condition or disease
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
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Digital Versus Analog Pleural Drainage in Patients With Pulmonary Air Leak
Study Start Date : January 2012
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Primary Outcome Measures :
  1. Inter-rater variability of air leak measurements. [ Time Frame: Post-op ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01566032

Canada, Ontario
Ottawa General Hospital
Ottawa, Ontario, Canada, K1H 8L6
Sponsors and Collaborators
Ottawa Hospital Research Institute
Principal Investigator: Sebastien Gilbert, MD Ottawa Hospital/Ottawa Hospital Research Institute

Responsible Party: Ottawa Hospital Research Institute Identifier: NCT01566032     History of Changes
Other Study ID Numbers: 2011619-01H
First Posted: March 29, 2012    Key Record Dates
Last Update Posted: July 7, 2017
Last Verified: July 2017

Keywords provided by Ottawa Hospital Research Institute:
pulmonary air leak