N/A
Completed N=490
Active Clearance of Chest Tubes After Cardiac Surgery: A Prospective Randomized Controlled Study
Source: ClinicalTrials.gov NCT02808897 ↗Enrolled (actual)
490
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcomePrimary: Number of Participants With Postoperative Atrial Fibrillation — 39; 33 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Postoperative Atrial Fibrillation |
39; 33 | — |
| SECONDARY Number of Participants Requiring Invasive Procedure for Intrathoracic Fluid Removal (Retained Blood Complications) |
27; 15 | — |
| SECONDARY Number of Participants Requiring Re-exploration for Bleeding or Tamponade |
14; 4 | — |
| SECONDARY Number of Participants Presenting With a Chest Tube Occlusion |
26; 42; 9; 14; 8; 1 | — |
| SECONDARY Number of Patients Requiring Pericardial Drainage Procedure |
5; 2 | — |
| SECONDARY Number of Patients Requiring Pleural Drainage Procedure |
8; 9 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02808897). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.