Clinical trial NCT02282462: Study of Postoperative Chest Tube Management
Official title: A Randomized Comparison of Active Suction vs. Passive Chest Tube Drainage and Regulated and Unregulated Pleural Pressure After Anatomic Lung Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lung Resection
Keywords: Chest tube
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Medela AG
First posted: 2014-11-04
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Duration of air leak
timeFrame: up to 7 days
Secondary outcomes:
measure: Time till chest tube removal
timeFrame: up to 7 days
Other outcomes:
measure: Duration of hospital stay
timeFrame: up to 7 days
measure: Amount of fluid drained
timeFrame: up to 7 days
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Marietta
country: United States
facility: WellStar Health System - Kennestone
state: Georgia
city: Boston
country: United States
facility: Beth Israel Deaconess/ Harvard
state: Massachusetts
city: Paramus
country: United States
facility: Valley Health System
state: New Jersey
city: Bethlehem
country: United States
facility: St. Luke's Hospital
state: Pennsylvania
Study officials:
affiliation: Yale University
name: Frank Detterbeck, MD
role: PRINCIPAL_INVESTIGATOR
References: