Study of Postoperative Chest Tube Management

Study Overview
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Brief Summary
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A 2 x 2 randomized study testing active versus passive drainage and regulated versus unregulated pleural pressure in patients undergoing anatomic lung resection

Detailed Description
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This study is a prospective, multi-center randomized clinical trial at 6 sites. Pre-operative evaluation and the decision for surgical intervention will proceed as currently performed at each center. That is, neither inclusion in nor exclusion from this study will affect the plan of care for patients other than the approach to chest tube management, which is determined by randomization among 4 methods that are in common clinical use. Each enrolled patient will be randomized to either regulated pleural pressure using the Thopaz+ digital chest drainage device or unregulated pleural pressure using a traditional system (multi-chambered system e.g. Pleur-Evac, Atrium-Maquet or similar device as is routine at each institution) and also randomized to either active suction (-20 cm H2O) or passive drainage.

Official Title
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A Randomized Comparison of Active Suction vs. Passive Chest Tube Drainage and Regulated and Unregulated Pleural Pressure After Anatomic Lung Resection

Conditions
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Lung Resection

Intervention / Treatment
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* Other: Reg Pressure
* Other: Unreg Pressure
* Other: Active Suction (Dig)
* Other: Active Suction (Trad)
* Other: Passive Drainage (Dig)
* Other: Passive Drainage (Trad)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able and willing to read, understand, and provide written consent Age 18-90 Undergoing a segmentectomy, lobectomy, or bilobectomy (including sleeve resection). Both open and minimally invasive (thoracoscopic or robotic) resections are acceptable Exclusion Criteria: Patients unstable enough to require ICU care for hemodynamic or respiratory problems during the first 7 days postoperatively. Patients admitted to the ICU for other reasons (e.g. bed availability, institutional norm, routine monitoring etc.) should NOT be excluded Patients undergoing non-anatomic lung resection only (i.e. wedge resection) Patients undergoing anatomic lung resection for bullous disease, lung abscess or bronchiectasis. Patients undergoing pneumonectomy or completion pneumonectomy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reg pressure, Active suction (Dig)<br>Regulated pleural pressure with active suction | Other: Reg Pressure<br>* Regulated Suction using the Thopaz+ digital chest drainage device<br>Other: Active Suction (Dig)<br>* Thopaz+ digital chest drainage device set at -20cmH2O at the patient<br>|
| Experimental: Reg pressure, Passive drainage (Dig)<br>Regulated pleural pressure with passive drainage | Other: Reg Pressure<br>* Regulated Suction using the Thopaz+ digital chest drainage device<br>Other: Passive Drainage (Dig)<br>* Thopaz+ digital chest drainage device set at -8cmH2O at the patient (physiologic)<br>|
| Experimental: Unreg pressure, Active suction (Trad)<br>Unregulated pleural pressure with active suction | Other: Unreg Pressure<br>* Unregulated Suction using a traditional system (multi-chambered system e.g. Pleur-Evac, Atrium-Maquet or similar device as is routine at each institution)<br>Other: Active Suction (Trad)<br>* Pleur-Evac, Atrium-Maquet or similar set at -20cmH2O at the device.<br>|
| Experimental: Unreg pressure, Passive drainage (Trad)<br>Unregulated pleural pressure with passive drainage | Other: Unreg Pressure<br>* Unregulated Suction using a traditional system (multi-chambered system e.g. Pleur-Evac, Atrium-Maquet or similar device as is routine at each institution)<br>Other: Passive Drainage (Trad)<br>* Pleur-Evac, Atrium-Maquet or similar set by gravity (water-seal')<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of air leak | Duration until there is no clinically significant air leak by standard criteria (no bubbles during coughing with a traditional device and a ≥6 hour period with no spikes >80 ml/min and an air flow ≤30 ml/min during passive drainage or ≤50 ml/min during active suction) | up to 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time till chest tube removal | Duration of time till chest tube is removed. Chest tube will be removed when resolution of air leak and fluid drainage <= 400 ml/day | up to 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chest tube