A Prospective Study of a New Device for Monitoring Cerebral Oxygenation on Healthy Volunteers

A Prospective Study With a New Device for the Monitoring of Cerebral Oxygenation on Healthy Volunteers

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

Study Overview

• Status: Completed
• Conditions: Cerebral Ischemia
• Intervention / Treatment: Device: CDI 1000 COM

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 effectivity.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • University of California, Irvine Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

INCLUSION CRITERIA:

• Healthy male or Female Volunteers
• 18 years old or older
• Capable and willing to operate a bicycle
• 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

EXLUSION CRITERIA:

• History of Cerebrovascular Disease
• History of Skin Problems on Forehead (Skin Rashes, Acne, Allergies, etc.)
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy Volunteers; Healthy subjects testing the device.	Device: CDI 1000 COM; CDI 1000 COM sensors were attached to subject's forehead for a 12 hour period.; Other Names: Terumo CDI 1000 COM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Harm to Skin From Attachment of Sensor to Forehead: Cuts, Bruising, Rash or Allergic Reactions to Adhesive.	Measurement of reactions to the sensor's attachment to the skin on the forehead. Measurement of the outcome is either reaction or no reaction. This means that all subjects are either measured as having a reaction at all or having no reaction at all. Measurement and reactions assessment performed by the investigator.	attachment of sensor to 24 hours post-removal
Overheating of Skin Underneath Sensor.	The Principal measure for this outcome was discomfort and potential harm from overheating while attached to an active study participant. The investigator of the study asked to the participant if he/she felt: • Discomfort in the sensor application zone; Itching, Burning sensation and/or Pain. The skin was examined before and after the sensor application. All the assessments were performed by the principal investigator of the study.	placement of sensor to 10 minutes post-removal.
Overheating of Skin Underneath Sensor	The Principal measure for this outcome was discomfort and potential harm from overheating while attached to an active study participant. The investigator of the study asked to the participant if he/she felt: • Discomfort in the sensor application zone; Itching, Burning sensation and/or Pain. The skin was examined before and after the sensor application. All the assessments were performed by the principal investigator of the study.	placement of sensor to immediately post-removal

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensor Fits Well on Subjects Forehead	How well the sensor seems to fit on the subject's forehead in terms of curvature, comfort and adherence. The fitting assessment was assessed visually and determined based in the size of the sensor and the length of forehead covered, also the adhesion test was performed by hanging weight of 2 LBS on the sensor for 10 min, recording if the sensor kept attached to the skin or not. All tests and measures were assessed by the investigator. All the characteristics of the sensor (curvature, comfort and adherence) were recorded on each subjects as "yes" or "no".	placement of sensor to end of study observation
Sensor Attachment Under Stress	The Principal measure for this outcome was discomfort and potential harm from overheating while attached to an active study participant. The investigator of the study asked to the participant if he/she felt: • Discomfort in the sensor application zone; Itching, Burning sensation and/or Pain. The skin was examined before and after the sensor application. All the assessments were performed by the principal investigator of the study.	addition of stress on sensor to removal.

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Investigators: Principal Investigator: Jeffrey C Milliken, MD, University of California, Irvine

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: December 19, 2007
• First Submitted That Met QC Criteria: January 22, 2008
• First Posted (Estimate): January 23, 2008

Study Record Updates

• Last Update Posted (Estimate): August 17, 2011
• Last Update Submitted That Met QC Criteria: August 15, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: Cerebral Oxygenation; Oxygen Monitoring
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Infarction; Stroke; Brain Infarction; Brain Ischemia; Ischemia; Cerebral Infarction
• Other Study ID Numbers: 2007-5593