High Frequency Ventilation During Off Pump Coronary Artery Bypass Graft (CABG) (VHF)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alain Deschamps, Montreal Heart Institute
ClinicalTrials.gov Identifier:
NCT00863044
First received: March 16, 2009
Last updated: March 15, 2016
Last verified: March 2016
  Purpose
This study is to test the safety of high frequency-low volume ventilation during off pump coronary artery bypass as reflected in the near infrared spectroscopy values for cerebral oxygenation.

Condition Intervention Phase
Coronary Artery Bypass Graft
Procedure: Apnea
Procedure: High frequency ventilation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of High Frequency Ventilation During Coronary Anastomosis in Off Pump Coronary Artery Bypass.

Resource links provided by NLM:


Further study details as provided by Montreal Heart Institute:

Primary Outcome Measures:
  • cerebral oxygen saturation [ Time Frame: during surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • hemodynamic parameters [ Time Frame: during surgery ] [ Designated as safety issue: Yes ]

Enrollment: 80
Study Start Date: November 2009
Study Completion Date: June 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: High frequency ventilation
high frequency ventilation
Procedure: High frequency ventilation
The patients will be ventilated using a tidal volume of 1.5 ml per Kg and a respiratory rate of 100 per minute for as long as the surgeon needs to perform the distal anastomosis of the coronaries.
Placebo Comparator: Apnea
lung ventilation will be stopped during distal anastomosis as is commonly done
Procedure: Apnea
Ventilation will be stopped for the duration of the anastomosis as it's done currently. At all other times during the surgery, the ventilatory parameters will be adjusted to maintain a PaCO2 between 40 and 45 mmHg.
Other Name: apnea during anastomosis in off pump CABG

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years.
  • Patients able to give consent with knowledge of french or english language.

Exclusion Criteria:

  • Patients undergoing emergency surgery.
  • Patients with an intra aortic balloon pump.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00863044

Locations
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Sponsors and Collaborators
Montreal Heart Institute
Investigators
Principal Investigator: Alain Deschamps, MD FRCPC Université de Montréal
  More Information

Publications:
John Murkin et al : Monitoring Brain oxygen saturation during coronary artery bypass surgery: A Randomised prospective study.
European Cardiovascular disease 2006 - 1-4, NT BNP in stable coronary artery diease

Responsible Party: Alain Deschamps, MD, PhD, FRCPC, Montreal Heart Institute
ClinicalTrials.gov Identifier: NCT00863044     History of Changes
Other Study ID Numbers: 08-1032 
Study First Received: March 16, 2009
Last Updated: March 15, 2016
Health Authority: Canada: Health Canada

Keywords provided by Montreal Heart Institute:
off pump coronary bypass
high frequency ventilation
cerebral oxygen saturation
vasopressors used
right and left ventricular function
arterial blood pressure
heart rate

ClinicalTrials.gov processed this record on August 25, 2016