An interventional study of Standard drainage and Active Tube Clearance drainage in Atrial Fibrillation, Pericardial Effusion and Pleural Effusion, sponsored by Montreal Heart Institute. Completed at 2 sites in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-06.
Sponsored by Montreal Heart Institute · Not applicable, Interventional, and Prevention
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.
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.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's enrollment of 520 is above the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Montreal Heart Institute is the lead sponsor of 101 studies on the registry; 24 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
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.
Time frame: From post index surgery through hospital discharge, an average of 30 days
Number of Participants Requiring Invasive Procedure for Intrathoracic Fluid Removal (Retained Blood Complications)
Any of the following: * Re-exploration for bleeding or cardiac tamponade * Pericardial drainage procedure (pericardiocentesis or pericardial window) * Pleural drainage procedure (thoracentesis, new chest tube, thoracoscopy or lateral thoracotomy)
Time frame: Within 30 days post index surgery
Number of Participants Requiring Re-exploration for Bleeding or Tamponade
Rate of re-exploration for bleeding or tamponade within 30-day post index surgery
Time frame: within 30-day post index surgery
Number of Participants Presenting With a Chest Tube Occlusion
Visual observation of mediastinal chest tube lumen upon removal to determine whether it is: * patent * partially occluded * totally occluded
Time frame: At chest tube removal
Number of Patients Requiring Pericardial Drainage Procedure
Rate of invasive pericardial drainage procedure within 30-day post index surgery
Time frame: within 30-day post index surgery
Number of Patients Requiring Pleural Drainage Procedure
Rate of invasive pleural drainage procedure within 30-day post index surgery
Time frame: within 30-day post index surgery
Number of Patients Being Readmitted
Frequency of readmission for any indication
Time frame: Within 30 days post index surgery
Total Chest Tube Output
Total chest tube output (milliliter)
Time frame: At chest tube removal
257 patients were randomized in the Active Tube Clearance (ATC) group for 263 in the standard drainage group prior to early dropouts. Respectively, 241 and 249 patients were followed for the duration of the trial. 100 random patients were included in the direct visual analysis: 57 and 43 in each respective group.
| Milestone | Standard Drainage | Active Tube Clearance Drainage |
|---|---|---|
| Started | 249 | 241 |
| Completed | 240 | 230 |
| Not completed | 9 | 11 |
| Withdrew: Lost to follow-up | 9 | 11 |
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.
| Participants | Standard Drainage | Active Tube Clearance Drainage |
|---|---|---|
| Number of Participants With Postoperative Atrial Fibrillation | 39 | 33 |
Any of the following: * Re-exploration for bleeding or cardiac tamponade * Pericardial drainage procedure (pericardiocentesis or pericardial window) * Pleural drainage procedure (thoracentesis, new chest tube, thoracoscopy or lateral thoracotomy)
| Participants | Standard Drainage | Active Tube Clearance Drainage |
|---|---|---|
| Number of Participants Requiring Invasive Procedure for Intrathoracic Fluid Removal (Retained Blood Complications) | 27 | 15 |
Rate of re-exploration for bleeding or tamponade within 30-day post index surgery
| Participants | Standard Drainage | Active Tube Clearance Drainage |
|---|---|---|
| Number of Participants Requiring Re-exploration for Bleeding or Tamponade | 14 | 4 |
Visual observation of mediastinal chest tube lumen upon removal to determine whether it is: * patent * partially occluded * totally occluded
| Participants | Standard Drainage | Active Tube Clearance Drainage |
|---|---|---|
| Patent | 26 | 42 |
| Partially obstructed | 9 | 14 |
| Totally obstructed | 8 | 1 |
Rate of invasive pericardial drainage procedure within 30-day post index surgery
| Participants | Standard Drainage | Active Tube Clearance Drainage |
|---|---|---|
| Number of Patients Requiring Pericardial Drainage Procedure | 5 | 2 |
Rate of invasive pleural drainage procedure within 30-day post index surgery
| Participants | Standard Drainage | Active Tube Clearance Drainage |
|---|---|---|
| Number of Patients Requiring Pleural Drainage Procedure | 8 | 9 |
Frequency of readmission for any indication
| Participants | Standard Drainage | Active Tube Clearance Drainage |
|---|---|---|
| Number of Patients Being Readmitted | 24 | 27 |
Total chest tube output (milliliter)
| milliliters | Standard Drainage | Active Tube Clearance Drainage |
|---|---|---|
| Total Chest Tube Output | 640 (430 to 815) | 580 (440 to 900) |
Collected over within 30-day post index surgery. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard Drainage | 4/240 (1.7%) | 0/240 (0%) | 0/230 (0%) |
| Active Tube Clearance Drainage | 3/230 (1.3%) | 0/230 (0%) | 0/240 (0%) |
| Age, Continuous(years) | Standard Drainage | Active Tube Clearance Drainage | Total |
|---|---|---|---|
| Mean | 65.9 ± 10.8 | 66.8 ± 8.3 | 66.3 ± 9.6 |
| Sex: Female, Male(Participants) | Standard Drainage | Active Tube Clearance Drainage | Total |
|---|---|---|---|
| Female | 53 | 46 | 99 |
| Male | 196 | 195 | 391 |
| Race and Ethnicity Not Collected(Participants) | Standard Drainage | Active Tube Clearance Drainage | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
The record gives a start of Nov 2015, a primary completion of Dec 2018 and a completion of Dec 2018. It does not say whether these dates are actual or estimated.
Results were first posted in Mar 2024, 5 years 3 months after primary completion.
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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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