Study of Postoperative Chest Tube Management

Phase 4

Completed

• Conditions: Lung Resection
• Interventions: Other: Reg Pressure; Other: Unreg Pressure; Other: Active Suction (Trad); Other: Active Suction (Dig); Other: Passive Drainage (Trad); Other: Passive Drainage (Dig)

• Registration Number: NCT02282462
• Lead Sponsor: Yale University

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.

Study Timeline

• Study First Submitted: 2014-10-30
• Study First Submitted QC: 2014-11-03
• Study First Posted: 2014-11-04
• Study Start: 2014-12
• Primary Completion: 2017-12-18
• Study Completion: 2017-12-18
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-24
• Last Update Posted: 2020-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Reg pressure, Passive drainage (Dig)	Reg Pressure	Regulated pleural pressure with passive drainage
Unreg pressure, Active suction (Trad)	Unreg Pressure	Unregulated pleural pressure with active suction
Unreg pressure, Active suction (Trad)	Active Suction (Trad)	Unregulated pleural pressure with active suction
Reg pressure, Active suction (Dig)	Reg Pressure	Regulated pleural pressure with active suction
Reg pressure, Active suction (Dig)	Active Suction (Dig)	Regulated pleural pressure with active suction
Unreg pressure, Passive drainage (Trad)	Passive Drainage (Trad)	Unregulated pleural pressure with passive drainage
Reg pressure, Passive drainage (Dig)	Passive Drainage (Dig)	Regulated pleural pressure with passive drainage
Unreg pressure, Passive drainage (Trad)	Unreg Pressure	Unregulated pleural pressure with passive drainage

Primary Outcome Measures

Name	Time	Method
Duration of air leak	up to 7 days	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)

Secondary Outcome Measures

Name	Time	Method
Time till chest tube removal	up to 7 days	Duration of time till chest tube is removed. Chest tube will be removed when resolution of air leak and fluid drainage \<= 400 ml/day

Trial Locations

Locations (5)

WellStar Health System - Kennestone; 🇺🇸 Marietta, Georgia, United States

St. Luke's Hospital; 🇺🇸 Bethlehem, Pennsylvania, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States

Beth Israel Deaconess/ Harvard; 🇺🇸 Boston, Massachusetts, United States

Valley Health System; 🇺🇸 Paramus, New Jersey, United States