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Completed

NCT Number: NCT01655940

Cerebral Oximeter Comparison Study

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.

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Key information

Conditions

Cardiac Bypass Patients

Sex eligibility

All sexes

Study type

Observational

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing cardiac surgery

Exclusion criteria

  • None

Treatment and study plan

Somanetics cerebral oximeter

Device

Somanetics cerebral oximeter

CASMED cerebral oximeter

Device

CASMED cerebral oximeter

Primary outcomes

  1. Oxygen saturation

    Time frame: during surgery - Day 1

    cannulation, decannulation, hemodynamic instability

Secondary outcomes

  1. Mean arterial pressure

    Time frame: during surgery - Day 1

    cannulation, decannulation, hemodynamic instability

Sponsors and collaborators

Lead sponsor

Nationwide Children's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Aug 2, 2012
Registry last updated
Aug 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.