Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Cerebral Oximeter Comparison Study

This study has been completed.
Information provided by (Responsible Party):
Aymen N Naguib, Nationwide Children's Hospital Identifier:
First received: May 17, 2011
Last updated: August 1, 2012
Last verified: July 2012

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.

Condition Intervention
Cardiac Bypass Patients
Device: Somanetics cerebral oximeter
Device: CASMED cerebral oximeter

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Comparison of the FORE-SITE and INVOS Cerebral Oximeters During Cardiac Surgery

Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • Oxygen saturation [ Time Frame: during surgery - Day 1 ] [ Designated as safety issue: No ]
    cannulation, decannulation, hemodynamic instability

Secondary Outcome Measures:
  • Mean arterial pressure [ Time Frame: during surgery - Day 1 ] [ Designated as safety issue: No ]
    cannulation, decannulation, hemodynamic instability

Enrollment: 50
Study Start Date: May 2011
Study Completion Date: December 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cardiac bypass patients Device: Somanetics cerebral oximeter
Somanetics cerebral oximeter
Device: CASMED cerebral oximeter
CASMED cerebral oximeter


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Cardiac bypass patients having surgery at Nationwide Children's Hospital


Inclusion Criteria:

  • Patients undergoing cardiac surgery

Exclusion Criteria:

  • None
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Please refer to this study by its identifier: NCT01655940

United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
  More Information

No publications provided

Responsible Party: Aymen N Naguib, Director of Pediatric Cardiothoracic Anesthesia, Nationwide Children's Hospital Identifier: NCT01655940     History of Changes
Other Study ID Numbers: IRB11-00256
Study First Received: May 17, 2011
Last Updated: August 1, 2012
Health Authority: United States: Institutional Review Board processed this record on March 01, 2015