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

NCT02808897 | Completed Results DMC

• 1 other identifier: MP-33-2015-1901
• Study Type: interventional
• Target: 520
• Locations: 1 country
• Sites: 2

Brief 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

Atrial Fibrillation; Pericardial Effusion; Pleural Effusion; Hemothorax; Cardiac Tamponade

Keywords

Chest tubes; Atrial fibrillation; Thoracic surgery; Critical care

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Postoperative Atrial Fibrillation

  Rate of any episode of new onset of Postoperative Atrial Fibrillation (POAF) in the study group. POAF is defined as any atrial fibrillation episode ≥ 60 min on telemetry or EKG. At any time between post index surgery through hospital discharge.

  From post index surgery through hospital discharge, an average of 30 days

Secondary Outcomes (5)

• Number of Participants Requiring Invasive Procedure for Intrathoracic Fluid Removal (Retained Blood Complications)

  Within 30 days post index surgery

• Number of Participants Requiring Re-exploration for Bleeding or Tamponade

  within 30-day post index surgery

• Number of Participants Presenting With a Chest Tube Occlusion

  At chest tube removal

• Number of Patients Requiring Pericardial Drainage Procedure

  within 30-day post index surgery

• Number of Patients Requiring Pleural Drainage Procedure

  within 30-day post index surgery

Other Outcomes (2)

• Number of Patients Being Readmitted

  Within 30 days post index surgery

• Total Chest Tube Output

  At chest tube removal

Study Arms (2)

Standard drainage

ACTIVE COMPARATOR

The control arm consist of consecutively enrolled cardiac surgery patients receiving one standard chest tube in the mediastinum and at most three (3) commercially available standard or silastic chest tubes in the mediastinal, right or left pleural space.

Device: Standard drainage

Active Tube Clearance drainage

EXPERIMENTAL

The test arm consists of consecutively enrolled cardiac surgery patients receiving one (1) chest tube using active tube clearance (PleuraFlow®) in the mediastinum and at most three (3) other commercially available standard or silastic chest tubes in the mediastinal, right or left pleural space.

Device: Active Tube Clearance drainage

Interventions

Standard drainage DEVICE

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.

Standard drainage

Active Tube Clearance drainage DEVICE

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.

Active Tube Clearance drainage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admission for coronary artery bypass graft (CABG), valve replacement or valve repair surgery, or a combination of these surgeries;
• Surgical procedure(s) on the ascending aorta and/or aortic arch that do not require deep hypothermic arrest (deep hypothermic arrest is defined as \< 18° C);
• Must be in sinus rhythm (SR) for a minimum of 30 days prior to the index surgery and at the start of the index surgery. No patient with history of atrial fibrillation.
• Sign the institutional review board/institutional ethics committee approved informed consent form after the nature of the study has been explained and questions/concern have been addressed.

You may not qualify if:

• Admitted for surgical treatment of arrhythmia or Atrial fibrillation history;
• Admitted for cardiac surgery requiring implantation/explantation of a Ventricular Assist Device (VAD) or heart transplant;
• Admitted for Transcatheter aortic valve replacement (TAVR);
• Cardiac surgical procedure that requires deep hypothermic arrest (as defined above);
• New or active endocarditis or myocarditis that is not adequately controlled with medication and/or requires surgical intervention;
• Documented inherited bleeding disorder(s);or
• History or known allergies to the device materials.
• Intervention carried out by a non-participating surgeon

Sponsors & Collaborators

• Montreal Heart Institute: lead
• ClearFlow, Inc.: collaborator
• Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal: collaborator

Study Sites (2)

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Hôpital du Sacré-Coeur de Montréal

Montreal, Quebec, H4J 1C5, Canada

Location

Related Publications (1)

• St-Onge S, Chauvette V, Hamad R, Bouchard D, Jeanmart H, Lamarche Y, Perrault LP, Demers P. Active clearance vs conventional management of chest tubes after cardiac surgery: a randomized controlled study. J Cardiothorac Surg. 2021 Mar 23;16(1):44. doi: 10.1186/s13019-021-01414-0.

  PMID: 33757537 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Pericardial Effusion; Pleural Effusion; Hemothorax; Cardiac Tamponade

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pleural Diseases; Respiratory Tract Diseases; Hemorrhage

Results Point of Contact

• Title: Philippe Demers
• Organization: Montreal Heart Institute

philippe.demers@icm-mhi.org

5143763330

Study Officials

• Philippe Demers, MD MSc

  Montreal Heart Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2016
• First Posted: June 22, 2016
• Study Start: November 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 6, 2024
• Results First Posted: March 6, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)