CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 520 enrolled
Drug / intervention
Standard drainage +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02808897
NCT02808897N/ACompleted
CompareCT.gov

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

Montreal Heart Institute·interventional·Posted Jun 22, 2016·Updated Mar 6, 2024

In Brief

A clinical study evaluating Standard drainage and Active Tube Clearance drainage for Atrial Fibrillation and 4 related conditions. Completed, enrolled 520 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation, Pericardial Effusion, Pleural Effusion, Hemothorax, Cardiac Tamponade
CountriesCanada
CollaboratorsClearFlow, Inc., Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 22, 2016
Enrollment StartNov 1, 2015
Primary CompletionDec 1, 2018
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 10.0 years ago

Interventions

Standard drainagedevice

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.

Active Tube Clearance drainagedevice

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.