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

NCT00863044 | Completed Phase 4

• 1 other identifier: 08-1032
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Bypass Graft

Keywords

off pump coronary bypass; high frequency ventilation; cerebral oxygen saturation; vasopressors used; right and left ventricular function; arterial blood pressure; heart rate

Outcome Measures

Primary Outcomes (1)

• cerebral oxygen saturation

  during surgery

Secondary Outcomes (1)

• hemodynamic parameters

  during surgery

Study Arms (2)

High frequency ventilation

ACTIVE COMPARATOR

high frequency ventilation

Procedure: High frequency ventilation

Apnea

PLACEBO COMPARATOR

lung ventilation will be stopped during distal anastomosis as is commonly done

Procedure: Apnea

Interventions

Apnea PROCEDURE

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.

Also known as: apnea during anastomosis in off pump CABG

Apnea

High frequency ventilation PROCEDURE

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.

High frequency ventilation

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients undergoing emergency surgery.
• Patients with an intra aortic balloon pump.

Sponsors & Collaborators

• Montreal Heart Institute: lead

Study Sites (1)

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

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MeSH Terms

Interventions

N(6)-2-(4-aminophenyl)ethyladenosine; High-Frequency Ventilation

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Alain Deschamps, MD FRCPC

  Université de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, FRCPC

Study Record Dates

• First Submitted: March 16, 2009
• First Posted: March 17, 2009
• Study Start: November 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: June 1, 2012
• Last Updated: March 16, 2016

Record last verified: 2016-03

Locations

CA (1)