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Study of Postoperative Chest Tube Management

NCT02282462 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2020-06-26

No results posted yet for this study

Summary

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

Conditions

  • Lung Resection

Interventions

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')

Sponsors & Collaborators

  • Medela AG

    collaborator INDUSTRY

  • Yale University

    lead OTHER

Principal Investigators

  • Frank Detterbeck, MD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2017-12-18
Completion
2017-12-18

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02282462 on ClinicalTrials.gov