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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01566032
First received: March 26, 2012
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

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
Pulmonary Air Leak

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Digital Versus Analog Pleural Drainage in Patients With Pulmonary Air Leak

Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • 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.


Enrollment: 30
Study Start Date: January 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01566032

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

No publications provided

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01566032     History of Changes
Other Study ID Numbers: 2011619-01H
Study First Received: March 26, 2012
Last Updated: March 17, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Ottawa Hospital Research Institute:
pulmonary air leak
Thopaz
analog
digital

ClinicalTrials.gov processed this record on April 17, 2014