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This study will evaluate the impact of continuous, digital pulmonary air leak monitoring on the duration of pleural drainage after lung resection in patients with and without a pulmonary air leak on postoperative day 1.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Air leak present - Analogue | Experimental | Patients randomized to Pleur Evac (Analogue drainage) monitoring system, air leak present. |
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| Air leak absent - Analogue (Pleur Evac) | Active Comparator | Patients randomized to Pleur Evac (Analogue drainage) monitoring system, no air leak present |
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| Air leak present - Digital (Thopaz) | Experimental | Patients with an air leak present, randomized to Thopaz (digital drainage) monitoring system. |
|
| Air leak absent - Digital (Thopaz) | Active Comparator | Patients randomized to digital system, no air leak present. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thopaz (Digital drainage) | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall length of hospitalization | Up to 5 days post-op (average) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first pleural drain removal | Over 24 hours post-op |
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Inclusion Criteria:
Elective pulmonary resection (i.e. wedge, segmentectomy, lobectomy, bilobectomy) for benign or neoplastic disease
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sebastien Gilbert, MD | Ottawa Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ottawa Hospital, General Campus | Ottawa | Ontario | K1H8L6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26409729 | Derived | 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. |
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| Pleur Evac (Analogue drainage) | Device |
|
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