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Active Clearance of Chest Tubes After Cardiac Surgery: A Prospective Randomized Controlled Study

NCT02808897 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 520

Last updated 2024-03-06

Study results available
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Summary

The purpose of this study is to assess the effectiveness of the PleuraFlow® Active Tube Clearance (ATC) technology in reducing the rate of postoperative atrial fibrillation (POAF) among post cardiac surgery patients and to evaluate the impact of Active Tube Clearance (ATC) on other complications, such as retained blood syndrome (RBS), a composite endpoint including re-exploration for bleeding or tamponade, and interventions for hemothorax, pericardial or pleural effusion.

Conditions

Interventions

DEVICE

Standard drainage

One (1) chest tube must be placed in the anterior mediastinum. The other chest tube(s) may be placed at the discretion of the operator. Chest tubes with internal diameter 28 French (Fr) shall be used. Use of silastic 19 Fr chest tubes were left at the discretion of the operating surgeon.

DEVICE

Active Tube Clearance drainage

One (1) PleuraFlow chest tube must be placed in the anterior mediastinum. The other chest tube(s) may be placed at the discretion of the operator. Chest tubes with internal diameter 28 Fr shall be used. Use of silastic 19 Fr chest tubes were left at the discretion of the operating surgeon.

Sponsors & Collaborators

  • ClearFlow, Inc.

    collaborator INDUSTRY

  • Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

    collaborator OTHER

  • Montreal Heart Institute

    lead OTHER

Principal Investigators

  • Philippe Demers, MD MSc · Montreal Heart Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT02808897 on ClinicalTrials.gov