Cerebral Oximeter Comparison Study

Completed

• Conditions: Cardiac Bypass Patients
• Interventions: Device: Somanetics cerebral oximeter; Device: CASMED cerebral oximeter

• Registration Number: NCT01655940
• Lead Sponsor: Nationwide Children's Hospital

Brief Summary

In this prospective study to try to standardize the care for patients, the investigators are planning to compare two cerebral oximeters currently in use at NCH in terms of their accuracy in determining the cerebral oxygen saturation as determined by jugular bulb oxygen saturation. Also, the investigators will compare these devices in terms of their response to changes in hemodynamics that occur during cardiac surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-17
• Primary Completion: 2011-10
• Study Completion: 2011-12
• Status Verified: 2012-07
• Study First Submitted QC: 2012-08-01
• Last Update Submitted: 2012-08-01
• Study First Posted: 2012-08-02
• Last Update Posted: 2012-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients undergoing cardiac surgery

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cardiac bypass patients	Somanetics cerebral oximeter	-
Cardiac bypass patients	CASMED cerebral oximeter	-

Primary Outcome Measures

Name	Time	Method
Oxygen saturation	during surgery - Day 1	cannulation, decannulation, hemodynamic instability

Secondary Outcome Measures

Name	Time	Method
Mean arterial pressure	during surgery - Day 1	cannulation, decannulation, hemodynamic instability

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States