Study of Postoperative Chest Tube Management

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2017-12-18

Brief Summary

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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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Detailed Description

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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

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Lung Resection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Reg pressure, Active suction (Dig)

Regulated pleural pressure with active suction

Group Type EXPERIMENTAL

Reg Pressure

Intervention Type OTHER

Regulated Suction using the Thopaz+ digital chest drainage device

Active Suction (Dig)

Intervention Type OTHER

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

Reg pressure, Passive drainage (Dig)

Regulated pleural pressure with passive drainage

Group Type EXPERIMENTAL

Reg Pressure

Intervention Type OTHER

Regulated Suction using the Thopaz+ digital chest drainage device

Passive Drainage (Dig)

Intervention Type OTHER

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

Unreg pressure, Active suction (Trad)

Unregulated pleural pressure with active suction

Group Type EXPERIMENTAL

Unreg Pressure

Intervention Type 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 (Trad)

Intervention Type OTHER

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

Unreg pressure, Passive drainage (Trad)

Unregulated pleural pressure with passive drainage

Group Type EXPERIMENTAL

Unreg Pressure

Intervention Type 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)

Passive Drainage (Trad)

Intervention Type OTHER

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

Interventions

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Reg Pressure

Regulated Suction using the Thopaz+ digital chest drainage device

Intervention Type 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)

Intervention Type OTHER

Active Suction (Dig)

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

Intervention Type OTHER

Active Suction (Trad)

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

Intervention Type OTHER

Passive Drainage (Dig)

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

Intervention Type OTHER

Passive Drainage (Trad)

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No