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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00598936
• Other study ID #: 2007-5840
• Status: Terminated
• Phase: Phase 1
• First received: December 24, 2007
• Last updated: September 1, 2011
• Start date: November 2007
• Est. completion date: May 2009

Study information

• Verified date: September 2011
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Valve Disease
• Heart Valve Diseases
• Myocardial Ischemia

Intervention

Device:
• CDI 1000 COM and INVOS 5100
CDI 1000 and INVOS 5100 sensors were attached to subject's forehead for a 12 hour period, digital photographs were taken before and after sensor placement.

Locations

Country	Name	City	State
United States	University of California, Irvine Medical Center	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To test a new device for Cerebral Oxygenation Monitoring		12 hours	Yes
Secondary	Safety of human forehead skin during period of probe adhesion		12 hours	Yes