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Cerebral Oximeter Comparison Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01655940
First Posted: August 2, 2012
Last Update Posted: August 2, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Aymen N Naguib, Nationwide Children's Hospital
  Purpose
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 Aymen N Naguib, Nationwide Children's Hospital:

Primary Outcome Measures:
  • Oxygen saturation [ Time Frame: during surgery - Day 1 ]
    cannulation, decannulation, hemodynamic instability


Secondary Outcome Measures:
  • Mean arterial pressure [ Time Frame: during surgery - Day 1 ]
    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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cardiac bypass patients having surgery at Nationwide Children's Hospital
Criteria

Inclusion Criteria:

  • Patients undergoing cardiac surgery

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01655940


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

Responsible Party: Aymen N Naguib, Director of Pediatric Cardiothoracic Anesthesia, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01655940     History of Changes
Other Study ID Numbers: IRB11-00256
First Submitted: May 17, 2011
First Posted: August 2, 2012
Last Update Posted: August 2, 2012
Last Verified: July 2012