- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02808897
Active Clearance of Chest Tubes After Cardiac Surgery: A Prospective Randomized Controlled Study (ACT-POAF)
Study Overview
Status
Intervention / Treatment
Detailed Description
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 ATC 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Samuel St-Onge
- Phone Number: (514) 929-4112
- Email: sam.st.onge@gmail.com
Study Contact Backup
- Name: Jonathan Lacharite
- Phone Number: 2640 (514) 376-3330
- Email: jonathan.lacharite@icm-mhi.org
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H4J 1C5
- Hopital du Sacre-Coeur de Montreal
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Montreal, Quebec, Canada, H1T 1C8
- Montreal Heart Institute
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard drainage
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.
|
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.
|
Experimental: Active Tube Clearance drainage
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Postoperative Atrial Fibrillation
Time Frame: From post index surgery through hospital discharge, an average of 30 days
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Requiring Invasive Procedure for Intrathoracic Fluid Removal (Retained Blood Complications)
Time Frame: Within 30 days post index surgery
|
Any of the following:
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Within 30 days post index surgery
|
Number of Participants Requiring Re-exploration for Bleeding or Tamponade
Time Frame: within 30-day post index surgery
|
Rate of re-exploration for bleeding or tamponade within 30-day post index surgery
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within 30-day post index surgery
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Number of Participants Presenting With a Chest Tube Occlusion
Time Frame: At chest tube removal
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Visual observation of mediastinal chest tube lumen upon removal to determine whether it is:
|
At chest tube removal
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Number of Patients Requiring Pericardial Drainage Procedure
Time Frame: within 30-day post index surgery
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Rate of invasive pericardial drainage procedure within 30-day post index surgery
|
within 30-day post index surgery
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Number of Patients Requiring Pleural Drainage Procedure
Time Frame: within 30-day post index surgery
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Rate of invasive pleural drainage procedure within 30-day post index surgery
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within 30-day post index surgery
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients Being Readmitted
Time Frame: Within 30 days post index surgery
|
Frequency of readmission for any indication
|
Within 30 days post index surgery
|
Total Chest Tube Output
Time Frame: At chest tube removal
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Total chest tube output (milliliter)
|
At chest tube removal
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Philippe Demers, MD MSc, Montreal Heart Institute
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MP-33-2015-1901
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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