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The Effect of Chest Tubes Using Active Clearance Technology® on the Incidence of Postoperative Atrial Fibrillation (ACT-POAF)

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ClinicalTrials.gov Identifier: NCT02808897
Recruitment Status : Unknown
Verified June 2016 by Montreal Heart Institute.
Recruitment status was:  Recruiting
First Posted : June 22, 2016
Last Update Posted : June 22, 2016
Sponsor:
Collaborators:
ClearFlow, Inc.
Hopital du Sacre-Coeur de Montreal
Information provided by (Responsible Party):
Montreal Heart Institute

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Pericardial Effusion Pleural Effusion Hemothorax Cardiac Tamponade Device: Standard drainage Device: Active Clearance Technology drainage Phase 4

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 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 508 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Atrial Fibrillation and Pericardial Drainage: Incidence of Postoperative Atrial Fibrillation According to the Type of Mediastinal Drainage Catheters
Study Start Date : November 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard drainage
The control arm consist of consecutively enrolled cardiac surgery patients receiving < four (4) commercially available standard chest tubes.
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) to 32 FR shall be used for the single anterior mediastinal chest tube.

Experimental: Active Clearance Technology drainage
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
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.)

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

Other Outcome Measures:
  1. Mortality [ Time Frame: Within 30 days post index surgery ]
  2. Length of hospital stay [ Time Frame: Within 30 days post index surgery ]
    Time until complete discharge (days)

  3. Stay in the Intensive care unit [ Time Frame: Within 30 days post index surgery ]
    Time until discharge from ICU (hours)

  4. Ventilation time [ Time Frame: Within 30 days post index surgery ]
    Time until extubation (hours)

  5. Postoperative transfusion [ Time Frame: Within 30 days post index surgery ]
    Total number and type of units transfused

  6. Total chest tube output first 24 hours [ Time Frame: Within 24 hours ]
    (mililiters)

  7. Total chest tube drainage [ Time Frame: Within 30 days post index surgery ]
    Time until chest tube removal (mililiters)

  8. Any cardiac arrest [ Time Frame: Within 30 days post index surgery ]
  9. Stroke [ Time Frame: Within 30 days post index surgery ]
  10. Renal failure requiring dialysis [ Time Frame: Within 30 days post index surgery ]
  11. Renal insufficiency [ Time Frame: Within 30 days post index surgery ]
    Serum creatinine level 3 times greater than baseline level or serum creat level > 300 μmol/L.

  12. Surgical site wound infection [ Time Frame: Within 30 days post index surgery ]

    One or more of the following:

    • Sternal Superficial Wound Infection
    • Deep Sternal Infection/Mediastinitis
    • Post-op Pneumonia

  13. Septicemia [ Time Frame: Within 30 days post index surgery ]
    Until hospital discharge

  14. Sepsis [ Time Frame: Within 30 days post index surgery ]
  15. Urinary tract infection [ Time Frame: Within 30 days post index surgery ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 < 14° 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02808897


Contacts
Contact: Samuel St-Onge (514) 929-4112 sam.st.onge@gmail.com
Contact: Jonathan Lacharité (514) 376-3330 ext 2640 jonathan.lacharite@icm-mhi.org

Locations
Canada, Quebec
Montreal Heart Institute Recruiting
Montreal, Quebec, Canada, H1T 1C8
Contact: Jonathan Lacharite    (514) 376-3330 ext 2640    jonathan.lacharite@icm-mhi.org   
Principal Investigator: Philippe Demers, MD MSc         
Hôpital du Sacré-Coeur de Montréal Recruiting
Montreal, Quebec, Canada, H4J 1C5
Contact: Hugues Jeanmart, MD    (514) 338-2222    hjeanmart@yahoo.com   
Sponsors and Collaborators
Montreal Heart Institute
ClearFlow, Inc.
Hopital du Sacre-Coeur de Montreal
Investigators
Principal Investigator: Philippe Demers, MD MSc Montreal Heart Institute

Responsible Party: Montreal Heart Institute
ClinicalTrials.gov Identifier: NCT02808897     History of Changes
Other Study ID Numbers: MP-33-2015-1901
First Posted: June 22, 2016    Key Record Dates
Last Update Posted: June 22, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Montreal Heart Institute:
Chest tubes
Atrial fibrillation
Thoracic surgery
Critical care

Additional relevant MeSH terms:
Atrial Fibrillation
Pleural Effusion
Pericardial Effusion
Hemothorax
Cardiac Tamponade
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Pleural Diseases
Respiratory Tract Diseases
Hemorrhage