Study of Postoperative Chest Tube Management

Lung Resection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02282462
• Other study ID #: 1411014891
• Status: Completed
• Phase: Phase 4
• Start date: December 2014
• Est. completion date: December 18, 2017

Study information

• Verified date: June 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: December 18, 2017
• Est. primary completion date: December 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Resection

Intervention

Other:
• Reg Pressure
Regulated Suction using the Thopaz+ digital chest drainage device
• Unreg Pressure
Unregulated Suction using a traditional system (multi-chambered system e.g. Pleur-Evac, Atrium-Maquet or similar device as is routine at each institution)
• Active Suction (Dig)
Thopaz+ digital chest drainage device set at -20cmH2O at the patient
• Active Suction (Trad)
Pleur-Evac, Atrium-Maquet or similar set at -20cmH2O at the device.
• Passive Drainage (Dig)
Thopaz+ digital chest drainage device set at -8cmH2O at the patient ("physiologic")
• Passive Drainage (Trad)
Pleur-Evac, Atrium-Maquet or similar set by gravity ("water-seal')

Locations

Country	Name	City	State
United States	St. Luke's Hospital	Bethlehem	Pennsylvania
United States	Beth Israel Deaconess/ Harvard	Boston	Massachusetts
United States	WellStar Health System - Kennestone	Marietta	Georgia
United States	Yale University	New Haven	Connecticut
United States	Valley Health System	Paramus	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Medela AG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Duration of hospital stay	How long is the total hospital stay	up to 7 days
Other	Amount of fluid drained	How much fluid is drained while the chest tube is in place	up to 7 days
Primary	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	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