Study of Postoperative Chest Tube Management

Yale University600 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

600

Conditions

Lung Resection

Interventions

Reg PressureOTHER

Regulated Suction using the Thopaz+ digital chest drainage device

Unreg PressureOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (5)

Yale University

New Haven, Connecticut, United States

WellStar Health System - Kennestone

Marietta, Georgia, United States

Beth Israel Deaconess/ Harvard

Boston, Massachusetts, United States

Valley Health System

Paramus, New Jersey, United States

Outcomes

Primary Outcomes

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)

Time frame: up to 7 days

Secondary Outcomes

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

Time frame: up to 7 days

Data from ClinicalTrials.gov

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