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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00863044
First Posted: March 17, 2009
Last Update Posted: March 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alain Deschamps, Montreal Heart Institute
  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
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.

Resource links provided by NLM:


Further study details as provided by Alain Deschamps, Montreal Heart Institute:

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

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

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

Information from the National Library of Medicine

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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.
  Contacts and Locations
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
  More Information

Publications:
3) Ratzenhofer-Komenda B,Prause G,Offner A,Smolle-Juttner FM et al Intra-opearative application of HFV in thoracic surgery Acta Anesthesiol Scand Suppl .1996 : 109 : 149-53
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
First Submitted: March 16, 2009
First Posted: March 17, 2009
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