Relation Between Mixed Venous Oxygen Saturation and Cerebral Oxygen Saturation Measured by Absolute and Relative Near-infrared Spectroscopy During Off-pump Coronary Artery Bypass Grafting.

This study has been completed.
Sponsor:
Collaborators:
Belgian Foundation for Cardiac Surgery
CAS Medical Systems, Inc.
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01673841
First received: August 17, 2012
Last updated: August 28, 2012
Last verified: August 2012
  Purpose

In this clinical study the investigators compared mixed venous oxygen saturation (SmvO2) with relative and absolute cerebral oxygen saturation (rScO2) measurements. They hypothesized that previously reported contradictory results regarding the equivalence of SmvO2 and rScO2 might be related to time delay issues and to the measurement technology.

42 consenting patients undergoing elective off-pump coronary artery bypass grafting were included. 4 disposable oxygenation sensors were applied bilaterally on the patient's forehead for continuous, non-invasive registration of rScO2. The sensors of one monitor were placed just above the eyebrows, and the sensors of the other monitor were placed just above the former sensors. The sensors placement was determined at random by a computerized randomization list. SmvO2 was measured continuously via a pulmonary artery catheter. All variables were recorded continuously. The study ended at the end of the operation.


Condition Intervention
Elective Off-pump Coronary Artery Bypass Grafting.
Procedure: Relative and absolute cerebral oxygen saturation (rScO2) measurements.

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Relation Between Mixed Venous Oxygen Saturation and Cerebral Oxygen Saturation Measured by Absolute and Relative Near-infrared Spectroscopy During Off-pump Coronary Artery Bypass Grafting.

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Correlation and time delay between mixed venous and cerebral oxygen saturation during off-pump coronary artery bypass grafting. [ Time Frame: 4 hours during an operation of average 5 hours (during off-pump coronary artery bypass grafting). ] [ Designated as safety issue: No ]
    Mixed venous oxygen saturation was measured continuously via a pulmonary artery catheter. Cerebral oxygen saturation was measured with near-infrared spectroscopy; the INVOS monitor to obtain relative measurements, and the Foresight monitor to obtain absolute data.


Secondary Outcome Measures:
  • The response of cerebral oxygen saturation to major haemodynamic disturbances. [ Time Frame: 2 hours after start of operation (during placement of deep pericardial stitches). ] [ Designated as safety issue: No ]
    Percentage difference between the cerebral oxygen saturation value just before heart retraction and the value at the different time moments.


Enrollment: 42
Study Start Date: October 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Relative + absolute cerebral oxygen saturation. Procedure: Relative and absolute cerebral oxygen saturation (rScO2) measurements.

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing elective off-pump coronary artery bypass grafting.

Criteria

Inclusion Criteria:

  • Patients undergoing elective off-pump coronary artery bypass grafting for at least 3-vessel coronary artery disease were eligible.

Exclusion Criteria:

  • Patients with arteriovenous shunts, intracardiac shunts, a previous history of cerebrovascular accident, or stenosis of the internal carotid artery of > 60% were excluded.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01673841

Locations
Belgium
Ghent University Hospital
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Belgian Foundation for Cardiac Surgery
CAS Medical Systems, Inc.
Investigators
Principal Investigator: Annelies Moerman, MD Ghent University Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01673841     History of Changes
Other Study ID Numbers: 2009/126
Study First Received: August 17, 2012
Last Updated: August 28, 2012
Health Authority: Belgium: Ethics Committee

Keywords provided by University Hospital, Ghent:
bypass grafting

ClinicalTrials.gov processed this record on October 01, 2014