Trial Outcomes & Findings for A Prospective Study of a New Device for Monitoring Cerebral Oxygenation on Healthy Volunteers (NCT NCT00598819)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

14 participants

Primary outcome timeframe

attachment of sensor to 24 hours post-removal

Results posted on

2011-08-17

Participant Flow

Healthy Volunteers

Physical Exam to confirm healthy status. The physical exam was performed by the investigator that is a licensed Medical Doctor.

Participant milestones

Participant milestones
Measure	Healthy Volunteers The participants were young adults (18 year-old or Older) who met the inclusion/exclusion criteria for the study and passed a physical exam. Subjects were fitted with the device, and laid down for 4 hours, sat upright for 30 minutes and rode an exercise bicycle for 30-45 minutes. The physical exam and device fitting was performed by the investigator.
Overall Study STARTED	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Volunteers n=14 Participants The participants were young adults (18 year-old or Older) who met the inclusion/exclusion criteria for the study and passed a physical exam. Subjects were fitted with the device, and laid down for 4 hours, sat upright for 30 minutes and rode an exercise bicycle for 30-45 minutes. The physical exam and device fitting was performed by the investigator.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants

PRIMARY outcome

Timeframe: attachment of sensor to 24 hours post-removal

Population: The number of participants was determined by protocol specifications.

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.

Outcome measures

Outcome measures
Measure	Healthy Volunteers n=14 Participants The participants were young adults (18 year-old or Older) who met the inclusion/exclusion criteria for the study and passed a physical exam. Subjects were fitted with the device, and laid down for 4 hours, sat upright for 30 minutes and rode an exercise bicycle for 30-45 minutes. The physical exam and device fitting was performed by the investigator.
Harm to Skin From Attachment of Sensor to Forehead: Cuts, Bruising, Rash or Allergic Reactions to Adhesive. Harm caused by sensor	0 Participants
Harm to Skin From Attachment of Sensor to Forehead: Cuts, Bruising, Rash or Allergic Reactions to Adhesive. No harm caused by sensor	14 Participants

PRIMARY outcome

Timeframe: placement of sensor to 10 minutes post-removal.

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.

Outcome measures

Outcome measures
Measure	Healthy Volunteers n=14 Participants The participants were young adults (18 year-old or Older) who met the inclusion/exclusion criteria for the study and passed a physical exam. Subjects were fitted with the device, and laid down for 4 hours, sat upright for 30 minutes and rode an exercise bicycle for 30-45 minutes. The physical exam and device fitting was performed by the investigator.
Overheating of Skin Underneath Sensor. Overheating underneath sensor	0 Participants
Overheating of Skin Underneath Sensor. No overheating underneath sensor	14 Participants

PRIMARY outcome

Timeframe: placement of sensor to immediately post-removal

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.

Outcome measures

Outcome measures
Measure	Healthy Volunteers n=14 Participants The participants were young adults (18 year-old or Older) who met the inclusion/exclusion criteria for the study and passed a physical exam. Subjects were fitted with the device, and laid down for 4 hours, sat upright for 30 minutes and rode an exercise bicycle for 30-45 minutes. The physical exam and device fitting was performed by the investigator.
Overheating of Skin Underneath Sensor Overheating underneath sensor	0 Participants
Overheating of Skin Underneath Sensor No overheating underneath sensor	14 Participants

SECONDARY outcome

Timeframe: placement of sensor to end of study observation

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".

Outcome measures

Outcome measures
Measure	Healthy Volunteers n=14 Participants The participants were young adults (18 year-old or Older) who met the inclusion/exclusion criteria for the study and passed a physical exam. Subjects were fitted with the device, and laid down for 4 hours, sat upright for 30 minutes and rode an exercise bicycle for 30-45 minutes. The physical exam and device fitting was performed by the investigator.
Sensor Fits Well on Subjects Forehead Sensor fit well	14 Participants
Sensor Fits Well on Subjects Forehead Sensor did not fit well	0 Participants

SECONDARY outcome

Timeframe: addition of stress on sensor to removal.

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.

Outcome measures

Outcome measures
Measure	Healthy Volunteers n=14 Participants The participants were young adults (18 year-old or Older) who met the inclusion/exclusion criteria for the study and passed a physical exam. Subjects were fitted with the device, and laid down for 4 hours, sat upright for 30 minutes and rode an exercise bicycle for 30-45 minutes. The physical exam and device fitting was performed by the investigator.
Sensor Attachment Under Stress Sensor gave out under stress	0 Participants
Sensor Attachment Under Stress Sensor held up to stress	14 Participants

Adverse Events

Healthy Volunteers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jeffrey C. Milliken

University of California, Irvine Medical Center

Phone: 714-456-3634

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60