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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.

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.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01673841
Enrollment
42
Registered
2012-08-28
Start date
2009-10-31
Completion date
2011-06-30
Last updated
2021-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elective Off-pump Coronary Artery Bypass Grafting

Keywords

bypass grafting

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.

Interventions

PROCEDURERelative and absolute cerebral oxygen saturation (rScO2) measurements.

Sponsors

Belgian Foundation for Cardiac Surgery
CollaboratorUNKNOWN
CAS Medical Systems, Inc.
CollaboratorINDUSTRY
University Hospital, Ghent
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
25 Years to 100 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Correlation and time delay between mixed venous and cerebral oxygen saturation during off-pump coronary artery bypass grafting.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

MeasureTime frameDescription
The response of cerebral oxygen saturation to major haemodynamic disturbances.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.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026