Cerebral Oximeter Comparison Study

August 1, 2012 updated by: Aymen N Naguib, Nationwide Children's Hospital

Comparison of the FORE-SITE and INVOS Cerebral Oximeters During Cardiac Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cardiac bypass patients having surgery at Nationwide Children's Hospital

Description

Inclusion Criteria:

  • Patients undergoing cardiac surgery

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cardiac bypass patients
Device: Somanetics cerebral oximeter
Somanetics cerebral oximeter
Device: CASMED cerebral oximeter
CASMED cerebral oximeter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygen saturation
Time Frame: during surgery - Day 1
cannulation, decannulation, hemodynamic instability
during surgery - Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean arterial pressure
Time Frame: during surgery - Day 1
cannulation, decannulation, hemodynamic instability
during surgery - Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nationwide Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

May 17, 2011

First Submitted That Met QC Criteria

August 1, 2012

First Posted (Estimate)

August 2, 2012

Study Record Updates

Last Update Posted (Estimate)

August 2, 2012

Last Update Submitted That Met QC Criteria

August 1, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • IRB11-00256

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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