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

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

Study Overview

• Status: Completed
• Conditions: Lung Resection
• Intervention / Treatment: Other: Reg Pressure; Other: Active Suction (Dig); Other: Passive Drainage (Dig); Other: Unreg Pressure; Other: Active Suction (Trad); Other: Passive Drainage (Trad)

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 Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Yale University
  • Georgia
    • Marietta, Georgia, United States, 30066
      • WellStar Health System - Kennestone
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess/ Harvard
  • New Jersey
    • Paramus, New Jersey, United States, 07653
      • Valley Health System
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • St. Luke's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reg pressure, Active suction (Dig); Regulated pleural pressure with active suction	Other: Reg Pressure; Regulated Suction using the Thopaz+ digital chest drainage device; Other: Active Suction (Dig); Thopaz+ digital chest drainage device set at -20cmH2O at the patient
Experimental: Reg pressure, Passive drainage (Dig); Regulated pleural pressure with passive drainage	Other: Reg Pressure; Regulated Suction using the Thopaz+ digital chest drainage device; Other: Passive Drainage (Dig); Thopaz+ digital chest drainage device set at -8cmH2O at the patient ("physiologic")
Experimental: Unreg pressure, Active suction (Trad); Unregulated pleural pressure with active suction	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 (Trad); Pleur-Evac, Atrium-Maquet or similar set at -20cmH2O at the device.
Experimental: Unreg pressure, Passive drainage (Trad); Unregulated pleural pressure with passive drainage	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: Passive Drainage (Trad); Pleur-Evac, Atrium-Maquet or similar set by gravity ("water-seal')

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of hospital stay	How long is the total hospital stay	up to 7 days
Amount of fluid drained	How much fluid is drained while the chest tube is in place	up to 7 days

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: Medela AG
• Investigators: Principal Investigator: Frank Detterbeck, MD, Yale University

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): December 18, 2017
• Study Completion (Actual): December 18, 2017

Study Registration Dates

• First Submitted: October 30, 2014
• First Submitted That Met QC Criteria: November 3, 2014
• First Posted (Estimate): November 4, 2014

Study Record Updates

• Last Update Posted (Actual): June 26, 2020
• Last Update Submitted That Met QC Criteria: June 24, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Chest tube
• Other Study ID Numbers: 1411014891