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Cerebral Oximeter Comparison Study

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01655940
Enrollment
50
Registered
2012-08-02
Start date
2011-05-31
Completion date
2011-12-31
Last updated
2012-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Bypass Patients

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.

Interventions

DEVICESomanetics cerebral oximeter

Somanetics cerebral oximeter

DEVICECASMED cerebral oximeter

CASMED cerebral oximeter

Sponsors

Nationwide Children's Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Patients undergoing cardiac surgery

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Oxygen saturationduring surgery - Day 1cannulation, decannulation, hemodynamic instability

Secondary

MeasureTime frameDescription
Mean arterial pressureduring surgery - Day 1cannulation, decannulation, hemodynamic instability

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026