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OpenTrials
Completed

NCT Number: NCT01566032

Digital Versus Analog Pleural Drainage in Patients With Pulmonary Air Leak

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.

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Key information

Conditions

Pulmonary Air Leak

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ottawa General Hospital

Ottawa, Ontario, K1H 8L6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Registry information

Acronym: DiVA

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 29, 2012
Registry last updated
Jul 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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