Digital Versus Analog Pleural Drainage in Patients With Pulmonary Air Leak

NCT ID: NCT01566032

Last Updated: 2017-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pulmonary Air Leak

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ottawa Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sebastien Gilbert, MD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Hospital/Ottawa Hospital Research Institute

Locations

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Ottawa General Hospital

Ottawa, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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2011619-01H

Identifier Type: -

Identifier Source: org_study_id

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