The Effect of Chest Tubes Using Active Clearance Technology® on the Incidence of Postoperative Atrial Fibrillation

Study Overview
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Brief Summary
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The purpose of this study is to assess the effectiveness of the PleuraFlow® Active Clearance Technology® (ACT) in reducing the rate of postoperative atrial fibrillation (POAF) among post cardiac surgery patients and to evaluate the impact of ACT 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.

Detailed Description
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Data will be collected and stored at the department of surgery of Montreal Heart Institute. Only the principal investigator and study coordinators will have access to the database. The primary analysis will be an intention-to-treat (ITT) analysis comparing the POAF rate in the PleuraFlow® group to the POAF rate in the control group. Based on findings from our institutional clinical database at the Montreal Heart Institute, the local incidence of POAF after cardiac surgery is approximately 25% (control group). The proportion in ACT group (the treatment group) is assumed to be 0,2500 under the null hypothesis and 0,1500 under the alternative hypothesis. Group sample sizes of 254 in each group achieve 80% power to detect a difference between the group proportions of 0,1000 using a Chi-Square test with a significance level of 0.0476. This significance level is computed using the O'Brien-Fleming method and accounts for the interim analysis that is planned after 300 randomized subjects have completed their 30-day follow-up. POAF and intervention to treat RBS rates and all other categorical event rates will be compared using chi-square tests. Multiple logistic regressions to adjust for potential confounding factors will also be used. Odds ratio and associated 95% confidence intervals will be computed for descriptive purpose. Goodness of fit will be checked using Hosmer-Lemeshow statistics. Quantitative endpoints will be investigated using Student t-tests. Analysis of covariance may also be used to account for potential confounding factors. Nonparametric tests or data transformation may be used if quantitative endpoints are not normally distributed. Correlations and associated 95% confidence intervals will be computed for descriptive purpose. An interim analysis will be conducted on the first 300 randomized subjects completing their 30-day follow-up. The primary endpoint (POAF rate) will be compared between the PleuraFlow® group and the control group using a chi-square test. The significance level for this test will be 0.0076, as computed using the O'Brien-Fleming method. If the p-value of the chi-square test is below this bound at the interim analysis, the study will be stopped for efficacy. Otherwise, the study will continue up to the planned 508 patients. As a result of this interim look, the final analysis of the primary endpoint would require a p < 0.0476 to be declared statistically significant. Analysis of the secondary endpoints and other outcomes will be conducted at the 0.05 significance level.

Official Title
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Atrial Fibrillation and Pericardial Drainage: Incidence of Postoperative Atrial Fibrillation According to the Type of Mediastinal Drainage Catheters

Conditions
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Atrial Fibrillation, Pericardial Effusion, Pleural Effusion, Hemothorax, Cardiac Tamponade

Intervention / Treatment
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* Device: Standard drainage
* Device: Active Clearance Technology drainage


Participation Criteria
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Eligibility Criteria
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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 < 14° 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard drainage<br>The control arm consist of consecutively enrolled cardiac surgery patients receiving < four (4) commercially available standard chest tubes. | Device: Standard drainage<br>* 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) to 32 FR shall be used for the single anterior mediastinal chest tube.<br>|
| Experimental: Active Clearance Technology drainage<br>The test arm consists of consecutively enrolled cardiac surgery patients receiving < two (2) PleuraFlow® chest tubes with Active Clearance Technology® and < two (2) other commercially available standard chest tubes. | Device: Active Clearance Technology drainage<br>* One (1) PleuraFlow chest tube must be placed in the anterior mediastinum with one (1) standard chest tube. The other chest tube(s) may be placed at the discretion of the operator. Chest tubes with internal diameter 28 FR to 32 FR shall be used for the single anterior mediastinal chest tube.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Within 30 days post index surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retained blood syndrome | One or more of the following: Re-exploration for bleeding, tamponade or washout of retained blood Any procedure to treat Pericardial effusion; i.e., pericardial window, pericardiocentesis, placement of pericardial drain Any procedure to treat Pleural effusion; i.e.,thoracentesis under any image-guided modality Any procedure to treat hemothorax (i.e., chest tube, thoracoscopy, thoracotomy, etc.) | Within 30 days post index surgery | 
| Readmission for any diagnosis of retained blood syndrome or postoperative atrial fibrillation |  | Within 30 days post index surgery | 
| Readmission for any reason |  | Within 30 days post index surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chest tubes, Atrial fibrillation, Thoracic surgery, Critical care