A Prospective Study of a New Device for Monitoring Cerebral Oxygenation on Healthy Volunteers - Full Text View

Purpose

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.

Condition	Intervention	Phase
Cerebral Ischemia	Device: CDI 1000 COM	Phase 1


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	A Prospective Study With a New Device for the Monitoring of Cerebral Oxygenation on Healthy Volunteers

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:

Harm to Skin From Attachment of Sensor to Forehead: Cuts, Bruising, Rash or Allergic Reactions to Adhesive. [ Time Frame: attachment of sensor to 24 hours post-removal ] [ Designated as safety issue: Yes ]
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.
Overheating of Skin Underneath Sensor. [ Time Frame: placement of sensor to 10 minutes post-removal. ] [ Designated as safety issue: Yes ]
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.
Overheating of Skin Underneath Sensor [ Time Frame: placement of sensor to immediately post-removal ] [ Designated as safety issue: Yes ]
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.

Secondary Outcome Measures:

Sensor Fits Well on Subjects Forehead [ Time Frame: placement of sensor to end of study observation ] [ Designated as safety issue: No ]
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".
Sensor Attachment Under Stress [ Time Frame: addition of stress on sensor to removal. ] [ Designated as safety issue: No ]
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.


Enrollment:	14
Study Start Date:	October 2007
Study Completion Date:	May 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: Terumo 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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00598819

Locations


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

Sponsors and Collaborators

University of California, Irvine

Investigators


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

More Information


Responsible Party:	Jeffrey Milliken, MD, University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00598819 History of Changes
Other Study ID Numbers:	2007-5593
Study First Received:	December 19, 2007
Results First Received:	January 15, 2010
Last Updated:	August 15, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Irvine:


Cerebral Oxygenation Oxygen Monitoring

Additional relevant MeSH terms:


Ischemia Brain Ischemia Cerebral Infarction Pathologic Processes Cerebrovascular Disorders Brain Diseases	Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Stroke

ClinicalTrials.gov processed this record on September 26, 2016