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Completed

NCT Number: NCT02282462

Study of Postoperative Chest Tube Management

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

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Key information

Conditions

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Yale University, New Haven, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reg Pressure

Other

Regulated Suction using the Thopaz+ digital chest drainage device

Unreg Pressure

Other

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)

Other

Thopaz+ digital chest drainage device set at -20cmH2O at the patient

Active Suction (Trad)

Other

Pleur-Evac, Atrium-Maquet or similar set at -20cmH2O at the device.

Passive Drainage (Dig)

Other

Thopaz+ digital chest drainage device set at -8cmH2O at the patient ("physiologic")

Passive Drainage (Trad)

Other

Pleur-Evac, Atrium-Maquet or similar set by gravity ("water-seal')

Primary outcomes

  1. Duration of air leak

    Time frame: 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 outcomes

  1. Time till chest tube removal

    Time frame: 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

Other outcomes

  1. Duration of hospital stay

    Time frame: up to 7 days

    How long is the total hospital stay

  2. Amount of fluid drained

    Time frame: up to 7 days

    How much fluid is drained while the chest tube is in place

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Medela AG

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Nov 4, 2014
Registry last updated
Jun 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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