Status:
COMPLETED
Study of Postoperative Chest Tube Management
Lead Sponsor:
Yale University
Collaborating Sponsors:
Medela AG
Conditions:
Lung Resection
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
Brief Summary
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
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. ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 18 2017
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT02282462
Start Date
December 1 2014
End Date
December 18 2017
Last Update
June 26 2020
Active Locations (5)
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1
Yale University
New Haven, Connecticut, United States, 06519
2
WellStar Health System - Kennestone
Marietta, Georgia, United States, 30066
3
Beth Israel Deaconess/ Harvard
Boston, Massachusetts, United States, 02215
4
Valley Health System
Paramus, New Jersey, United States, 07653