A Prospective Study With a New Device for the Monitoring of Cerebral Oxygenation on Cardiac Surgery Patients

Terminated

• Conditions: Coronary Artery Disease; Heart Valve Disease
• Interventions: Device: CDI 1000 COM and INVOS 5100

• Registration Number: NCT00598936
• Lead Sponsor: University of California, Irvine

Brief Summary

The purpose of this study is to determine whether a new cerebral oxygenation monitoring device is comparatively similar to the current approved devices.

Detailed Description

Cerebral oxygenation monitoring is an innovative way to monitoring cardiac surgery patients intraoperatively to reduce the incidence of postoperative hypoxic side effects. There are a number of approved devices already in the market that have proved their efficacy.

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-12-24
• Study First Submitted QC: 2008-01-22
• Study First Posted: 2008-01-23
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-01
• Last Update Posted: 2011-09-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

1. To be 18 years old or older
2. Scheduled for cardiac surgery
3. Treatment will include 72 hours or more of hospital stay
4. Understand enough about the risks and benefits of the study to be able to make an informed decision before agreeing to be in the study

Exclusion Criteria

1. History of cerebrovascular disease
2. History of skin problems on forehead (skin rashes, acne, allergies, etc.)
3. History of craniofacial surgeries
4. Pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cardiac Surgery or Hospitalization	CDI 1000 COM and INVOS 5100	Patients scheduled for a Cardiac Surgery procedure, two types of cerebral oximetry devices were compared at the same time during the surgical procedure. The second group were patients hospitalized (in the Intensive Care Unit or ICU, with any diagnosis, excluding head trauma patients. Those patients were monitored using two types of cerebral oximetry devices at the same time for up to 72 hours.

Primary Outcome Measures

Name	Time	Method
To test a new device for Cerebral Oxygenation Monitoring	12 hours

Secondary Outcome Measures

Name	Time	Method
Safety of human forehead skin during period of probe adhesion	12 hours

Trial Locations

Locations (1)

University of California, Irvine Medical Center; 🇺🇸 Orange, California, United States