Active Clearance of Chest Tubes After Cardiac Surgery: A Prospective Randomized Controlled Study

Atrial Fibrillation Clinical Trial

Official title:

Active Clearance of Chest Tubes After Cardiac Surgery: A Prospective Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02808897
• Other study ID #: MP-33-2015-1901
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: December 2018

Study information

• Verified date: August 2023
• Source: Montreal Heart Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 520
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Admission for coronary artery bypass graft (CABG), valve replacement or valve repair surgery, or a combination of these surgeries;

2. 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);

3. 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.

4. 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:

1. Admitted for surgical treatment of arrhythmia or Atrial fibrillation history;

2. Admitted for cardiac surgery requiring implantation/explantation of a Ventricular Assist Device (VAD) or heart transplant;

3. Admitted for Transcatheter aortic valve replacement (TAVR);

4. Cardiac surgical procedure that requires deep hypothermic arrest (as defined above);

5. New or active endocarditis or myocarditis that is not adequately controlled with medication and/or requires surgical intervention;

6. Documented inherited bleeding disorder(s);or

7. History or known allergies to the device materials.

8. Intervention carried out by a non-participating surgeon

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cardiac Tamponade
• Hemothorax
• Pericardial Effusion
• Pleural Effusion

Intervention

Device:
• Standard 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.
• Active Tube Clearance drainage
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.

Locations

Country	Name	City	State
Canada	Hôpital du Sacré-Coeur de Montréal	Montreal	Quebec
Canada	Montreal Heart Institute	Montreal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Montreal Heart Institute	ClearFlow, Inc., Hopital du Sacre-Coeur de Montreal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Patients Being Readmitted	Frequency of readmission for any indication	Within 30 days post index surgery
Other	Total Chest Tube Output	Total chest tube output (milliliter)	At chest tube removal
Primary	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.	From post index surgery through hospital discharge, an average of 30 days
Secondary	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)	Within 30 days post index surgery
Secondary	Number of Participants Requiring Re-exploration for Bleeding or Tamponade	Rate of re-exploration for bleeding or tamponade within 30-day post index surgery	within 30-day post index surgery
Secondary	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	At chest tube removal
Secondary	Number of Patients Requiring Pericardial Drainage Procedure	Rate of invasive pericardial drainage procedure within 30-day post index surgery	within 30-day post index surgery
Secondary	Number of Patients Requiring Pleural Drainage Procedure	Rate of invasive pleural drainage procedure within 30-day post index surgery	within 30-day post index surgery