NCT02282462

Study of Postoperative Chest Tube Management

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Resection

Interventions

Type	Name	Description
OTHER	Reg Pressure	Regulated Suction using the Thopaz+ digital chest drainage device
OTHER	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)
OTHER	Active Suction (Dig)	Thopaz+ digital chest drainage device set at -20cmH2O at the patient
OTHER	Active Suction (Trad)	Pleur-Evac, Atrium-Maquet or similar set at -20cmH2O at the device.
OTHER	Passive Drainage (Dig)	Thopaz+ digital chest drainage device set at -8cmH2O at the patient ("physiologic")
OTHER	Passive Drainage (Trad)	Pleur-Evac, Atrium-Maquet or similar set by gravity ("water-seal')

Timeline

• Start date: 2014-12-01
• Primary completion: 2017-12-18
• Completion: 2017-12-18
• First posted: 2014-11-04
• Last updated: 2020-06-26

Locations

5 sites across 1 country: United States