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.

Completed

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

• Registration Number: NCT01673841
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Study First Submitted: 2012-08-17
• Study First Submitted QC: 2012-08-23
• Study First Posted: 2012-08-28
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-07
• Last Update Posted: 2021-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Relative + absolute cerebral oxygen saturation.	Relative and absolute cerebral oxygen saturation (rScO2) measurements.	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Ghent University Hospital; 🇧🇪 Ghent, Belgium