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Trial Outcomes & Findings for Validation of Brain Oxygenation Monitor (NCT NCT00815490)

NCT ID: NCT00815490

Last Updated: 2013-04-16

Results Overview

A scatterplot is created with the forehead sensor saturation on the y-axis and the measured blood saturation on the x-axis. The line of identity is drawn representing the ideal points, meaning that the forehead sensor saturation is always the same as the blood saturation. The dispersion of the actual data points around this line of identity can be measured using a statistical calculation called Arithmetic Root Mean Square or ARMS. The smaller the ARMS the closer the data points lie around the line of identity, representing a more accurate sensor.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

18 participants

Primary outcome timeframe

Data collected from individual participants over 1 hour timeframe. Data from cohort of subjects collected over 6 month period.

Results posted on

2013-04-16

Participant Flow

Recruitment 10/2007 - 12/2008 at Duke University Medical Center.

Healthy volunteers recruited with specific exclusion of anemia \& hemoglobinopathy.

Participant milestones

Participant milestones
Measure
Calibration
Initial group of subjects on whom the test algorithm is developed.
Validation
Group of subjects in whom the final algorithm is tested.
Overall Study
STARTED
9
9
Overall Study
COMPLETED
9
9
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Validation of Brain Oxygenation Monitor

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Calibration
n=9 Participants
Initial group of subjects on whom the test algorithm is developed.
Validation
n=9 Participants
Group of subjects in whom the final algorithm is tested.
Total
n=18 Participants
Total of all reporting groups
Age Continuous
25 Years
n=5 Participants
26 Years
n=7 Participants
25.7 Years
n=5 Participants
Sex: Female, Male
Female
4 Participants
n=5 Participants
4 Participants
n=7 Participants
8 Participants
n=5 Participants
Sex: Female, Male
Male
5 Participants
n=5 Participants
5 Participants
n=7 Participants
10 Participants
n=5 Participants
Race/Ethnicity, Customized
Hispanic
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Race/Ethnicity, Customized
African American
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
Race/Ethnicity, Customized
Caucasian
6 Participants
n=5 Participants
7 Participants
n=7 Participants
13 Participants
n=5 Participants
Race/Ethnicity, Customized
Asian
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Data collected from individual participants over 1 hour timeframe. Data from cohort of subjects collected over 6 month period.

Population: Multiple data points from each individual were pooled and presented as group data.

A scatterplot is created with the forehead sensor saturation on the y-axis and the measured blood saturation on the x-axis. The line of identity is drawn representing the ideal points, meaning that the forehead sensor saturation is always the same as the blood saturation. The dispersion of the actual data points around this line of identity can be measured using a statistical calculation called Arithmetic Root Mean Square or ARMS. The smaller the ARMS the closer the data points lie around the line of identity, representing a more accurate sensor.

Outcome measures

Outcome measures
Measure
Calibration
n=9 Participants
Initial group of subjects on whom the test algorithm is developed.
Validation
n=9 Participants
Group of subjects in whom the final algorithm is tested.
Accuracy of Sensor
3.0 percentage saturation
Interval 2.6 to 3.5
8.1 percentage saturation
Interval 7.0 to 9.6

Adverse Events

Calibration

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Validation

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 David MacLeod

Duke University Medical Center

Phone: 919-812-3201

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place