Digital Versus Analog Pleural Drainage Following Pulmonary Resection
NCT ID: NCT01775657
Last Updated: 2022-11-21
Study Results
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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COMPLETED
NA
176 participants
INTERVENTIONAL
2013-01-31
2021-12-01
Brief Summary
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Patients undergoing pulmonary resection who fit the inclusion criteria will be identified pre-operatively. Patients within two groups (air leak and no air leak) will be randomized to receive either the analogue system or the digital system. Both systems are approved for use in hospitals by Health Canada. There will be 88 patients in each air leak group.
Hypothesis: Continuous, quantitative monitoring of PAL following lung resection leads to an improvement in primary outcomes.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Air leak present - Analogue
Patients randomized to Pleur Evac (Analogue drainage) monitoring system, air leak present.
Pleur Evac (Analogue drainage)
Air leak absent - Analogue (Pleur Evac)
Patients randomized to Pleur Evac (Analogue drainage) monitoring system, no air leak present
Pleur Evac (Analogue drainage)
Air leak present - Digital (Thopaz)
Patients with an air leak present, randomized to Thopaz (digital drainage) monitoring system.
Thopaz (Digital drainage)
Air leak absent - Digital (Thopaz)
Patients randomized to digital system, no air leak present.
Thopaz (Digital drainage)
Interventions
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Thopaz (Digital drainage)
Pleur Evac (Analogue drainage)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Pneumonectomy
3. Patient no longer within planned randomization window
4. Plan to remove or removal of all chest drains within 36 hours of surgery
5. Inability to provide informed consent
6. Age \< 18 years
7. Patient was previously randomized following pulmonary resection
18 Years
ALL
No
Sponsors
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Ottawa Hospital Research Institute
OTHER
Responsible Party
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Principal Investigators
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Sebastien Gilbert, MD
Role: PRINCIPAL_INVESTIGATOR
Ottawa Hospital Research Institute
Locations
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Ottawa Hospital, General Campus
Ottawa, Ontario, Canada
Countries
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References
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Gilbert S, McGuire AL, Maghera S, Sundaresan SR, Seely AJ, Maziak DE, Shamji FM, Villeneuve PJ. Randomized trial of digital versus analog pleural drainage in patients with or without a pulmonary air leak after lung resection. J Thorac Cardiovasc Surg. 2015 Nov;150(5):1243-9. doi: 10.1016/j.jtcvs.2015.08.051. Epub 2015 Aug 28.
Other Identifiers
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20120228-01H
Identifier Type: -
Identifier Source: org_study_id
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