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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary: 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 Summary:

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 completin
Sponsor: Montreal Heart Institute

Current Primary Outcome: Postoperative atrial fibrillation [ Time Frame: Within 30 days post index surgery ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Retained blood syndrome [ Time Frame: Within 30 days post index surgery ]

    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.)
  • Readmission for any diagnosis of retained blood syndrome or postoperative atrial fibrillation [ Time Frame: Within 30 days post index surgery ]
  • Readmission for any reason [ Time Frame: Within 30 days post index surgery ]


Original Secondary Outcome: Same as current

Information By: Montreal Heart Institute

Dates:
Date Received: June 14, 2016
Date Started: November 2015
Date Completion: October 2017
Last Updated: June 17, 2016
Last Verified: June 2016