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: October 28, 2013
Last verified: October 2013
  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 ]

Estimated 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.
Other Name: high frequency ventilation
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
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
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:
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
4) Babinski MF,Smith RB et al: High frequency ventilation.Int Anesthesiol Clin 1986:24:75-92

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: October 28, 2013
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 April 17, 2014