Digital Versus Analog Pleural Drainage Following Pulmonary Resection

Study Overview
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Brief Summary
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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.

Official Title
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Digital Versus Analog Pleural Drainage Following Pulmonary Resection

Conditions
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Pulmonary Air Leak, Lobectomy, Wedge Resection, Segmentectomy

Intervention / Treatment
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* Device: Thopaz (Digital drainage)
* Device: Pleur Evac (Analogue drainage)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective pulmonary resection (i.e. wedge, segmentectomy, lobectomy, bilobectomy) for benign or neoplastic disease Exclusion Criteria: Development of tension pneumothorax Pneumonectomy Patient no longer within planned randomization window Plan to remove or removal of all chest drains within 36 hours of surgery Inability to provide informed consent Age < 18 years Patient was previously randomized following pulmonary resection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Air leak present - Analogue<br>Patients randomized to Pleur Evac (Analogue drainage) monitoring system, air leak present. | Device: Pleur Evac (Analogue drainage)<br> <br> * Other names: Pleur Evac A-6002-08, Teleflex Inc, Research Triangle Park, NC, USA;|
| Active Comparator: Air leak absent - Analogue (Pleur Evac)<br>Patients randomized to Pleur Evac (Analogue drainage) monitoring system, no air leak present | Device: Pleur Evac (Analogue drainage)<br> <br> * Other names: Pleur Evac A-6002-08, Teleflex Inc, Research Triangle Park, NC, USA;|
| Experimental: Air leak present - Digital (Thopaz)<br>Patients with an air leak present, randomized to Thopaz (digital drainage) monitoring system. | Device: Thopaz (Digital drainage)<br> <br> * Other names: Thopaz, Medela Switzerland;|
| Active Comparator: Air leak absent - Digital (Thopaz)<br>Patients randomized to digital system, no air leak present. | Device: Thopaz (Digital drainage)<br> <br> * Other names: Thopaz, Medela Switzerland;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall length of hospitalization |  | Up to 5 days post-op (average) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first pleural drain removal |  | Over 24 hours post-op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulmonary air leak, Thopaz, digital, analog, randomized