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

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ClinicalTrials.gov Identifier: NCT00863044
Recruitment Status : Completed
First Posted : March 17, 2009
Last Update Posted : March 16, 2016
Sponsor:
Information provided by (Responsible Party):
Alain Deschamps, Montreal Heart Institute

Brief Summary:
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 or disease Intervention/treatment Phase
Coronary Artery Bypass Graft Procedure: Apnea Procedure: High frequency ventilation Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of High Frequency Ventilation During Coronary Anastomosis in Off Pump Coronary Artery Bypass.
Study Start Date : November 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. cerebral oxygen saturation [ Time Frame: during surgery ]

Secondary Outcome Measures :
  1. hemodynamic parameters [ Time Frame: during surgery ]


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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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): 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

Publications:
John Murkin et al : Monitoring Brain oxygen saturation during coronary artery bypass surgery: A Randomised prospective study.
Tillett WS, Francis Jr T (1930).
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
First Posted: March 17, 2009    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 2016

Keywords provided by Alain Deschamps, 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