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.

NCT ID: NCT01673841

Last Updated: 2021-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Elective Off-pump Coronary Artery Bypass Grafting

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Relative + absolute cerebral oxygen saturation.

Relative and absolute cerebral oxygen saturation (rScO2) measurements.

Intervention Type PROCEDURE

Interventions

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Relative and absolute cerebral oxygen saturation (rScO2) measurements.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Belgian Foundation for Cardiac Surgery

UNKNOWN

Sponsor Role collaborator

CAS Medical Systems, Inc.

INDUSTRY

Sponsor Role collaborator

University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Annelies Moerman, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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Ghent University Hospital

Ghent, , Belgium

Site Status

Countries

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Belgium

Related Links

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Other Identifiers

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2009/126

Identifier Type: -

Identifier Source: org_study_id

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