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.

NCT01673841 | Completed

• 1 other identifier: 2009/126
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Elective Off-pump Coronary Artery Bypass Grafting

Keywords

bypass grafting

Outcome Measures

Primary Outcomes (1)

• Correlation and time delay between mixed venous and cerebral oxygen saturation 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.

  4 hours during an operation of average 5 hours (during off-pump coronary artery bypass grafting).

Secondary Outcomes (1)

• The response of cerebral oxygen saturation to major haemodynamic disturbances.

  2 hours after start of operation (during placement of deep pericardial stitches).

Study Arms (1)

Relative + absolute cerebral oxygen saturation.

Procedure: Relative and absolute cerebral oxygen saturation (rScO2) measurements.

Interventions

Relative and absolute cerebral oxygen saturation (rScO2) measurements. PROCEDURE

Relative + absolute cerebral oxygen saturation.

Eligibility Criteria

• Age: 25 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing elective off-pump coronary artery bypass grafting.

You may qualify if:

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

You may not qualify if:

• Patients with arteriovenous shunts, intracardiac shunts, a previous history of cerebrovascular accident, or stenosis of the internal carotid artery of \> 60% were excluded.

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Belgian Foundation for Cardiac Surgery: collaborator
• CAS Medical Systems, Inc.: collaborator

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

Related Links

• Related Info

MeSH Terms

Interventions

Weights and Measures

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Annelies Moerman, MD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2012
• First Posted: August 28, 2012
• Study Start: October 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: July 13, 2021

Record last verified: 2021-07

Locations

BE (1)