Study of Postoperative Chest Tube Management



Status:Recruiting
Healthy:No
Age Range:18 - 90
Updated:10/26/2017
Start Date:December 2014
End Date:May 2018
Contact:Frank Detterbeck, MD
Email:frank.detterbeck@yale.edu
Phone:203-785-4931

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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

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

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.

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
We found this trial at
5
sites
Boston, Massachusetts
Phone: 617-632-8252
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Bethlehem, Pennsylvania 18015
Phone: 610-954-3990
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Bethlehem, PA
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677 Church Street
Marietta, Georgia 30066
Phone: 770-424-9732
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New Haven, Connecticut 6520
(203) 432-4771
Phone: 203-785-4931
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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Paramus, New Jersey 07653
Phone: 201-634-5365
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Paramus, NJ
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