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

Cerebral Ischemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00598819
• Other study ID #: 2007-5593
• Status: Completed
• Phase: Phase 1
• First received: December 19, 2007
• Last updated: August 15, 2011
• Start date: October 2007
• Est. completion date: May 2009

Study information

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

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cerebral Infarction
• Cerebral Ischemia

Intervention

Device:
• CDI 1000 COM
CDI 1000 COM sensors were attached to subject's forehead for a 12 hour period.

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	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	Yes
Primary	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.	Yes
Primary	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	Yes
Secondary	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	No
Secondary	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.	No