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
-
-
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
|
Somanetics 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
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.