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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.

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ClinicalTrials.gov Identifier: NCT01673841
Recruitment Status : Completed
First Posted : August 28, 2012
Last Update Posted : August 29, 2012
Sponsor:
Collaborators:
Belgian Foundation for Cardiac Surgery
CAS Medical Systems, Inc.
Information provided by (Responsible Party):
University Hospital, Ghent

Brief Summary:

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

Study Type : Observational
Actual Enrollment : 42 participants
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.
Study Start Date : October 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

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U.S. FDA Resources

Group/Cohort Intervention/treatment
Relative + absolute cerebral oxygen saturation. Procedure: Relative and absolute cerebral oxygen saturation (rScO2) measurements.



Primary Outcome Measures :
  1. 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). ]
    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 :
  1. The response of cerebral oxygen saturation to major haemodynamic disturbances. [ Time Frame: 2 hours after start of operation (during placement of deep pericardial stitches). ]
    Percentage difference between the cerebral oxygen saturation value just before heart retraction and the value at the different time moments.



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Ages Eligible for Study:   25 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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): 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 University Hospital, Ghent

Additional Information:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01673841     History of Changes
Other Study ID Numbers: 2009/126
First Posted: August 28, 2012    Key Record Dates
Last Update Posted: August 29, 2012
Last Verified: August 2012

Keywords provided by University Hospital, Ghent:
bypass grafting