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Nonin 4 Wavelength Cerebral Oximeter Study (Nonin4)

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ClinicalTrials.gov Identifier: NCT01762722
Recruitment Status : Completed
First Posted : January 8, 2013
Results First Posted : April 16, 2013
Last Update Posted : April 16, 2013
Sponsor:
Collaborator:
Nonin Medical, Inc
Information provided by (Responsible Party):
David MacLeod, Duke University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Healthy
Intervention Device: Reduction of inspired oxygen
Enrollment 23
Recruitment Details Recruitment 09/2009 - 06/2010 at Duke University Medical Center.
Pre-assignment Details Healthy volunteers recruited with specific exclusion of anemia & hemoglobinopathy.
Arm/Group Title Calibration Validation
Hide Arm/Group Description Initial group of subjects on whom the test algorithm is developed. Group of subjects in whom the final algorithm is tested.
Period Title: Overall Study
Started 12 11
Completed 12 11
Not Completed 0 0
Arm/Group Title Calibration Validation Total
Hide Arm/Group Description Initial group of subjects on whom the test algorithm is developed. Group of subjects in whom the final algorithm is tested. Total of all reporting groups
Overall Number of Baseline Participants 12 11 23
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 12 participants 11 participants 23 participants
27
(22 to 36)
25
(21 to 31)
25
(21 to 34)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 11 participants 23 participants
Female
3
  25.0%
6
  54.5%
9
  39.1%
Male
9
  75.0%
5
  45.5%
14
  60.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 12 participants 11 participants 23 participants
Hispanic 0 0 0
African American 2 3 5
Caucasian 10 8 18
Asian 0 0 0
1.Primary Outcome
Title Accuracy of Sensor
Hide Description 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.
Time Frame Data collected from individual participants over 1 hour timeframe. Data from cohort of subjects collected over 6 month period.
Hide Outcome Measure Data
Hide Analysis Population Description
Multiple data points from each individual were pooled and presented as group data.
Arm/Group Title Calibration Validation
Hide Arm/Group Description:
Initial group of subjects on whom the test algorithm is developed.
Group of subjects in whom the final algorithm is tested.
Overall Number of Participants Analyzed 12 11
Mean (Full Range)
Unit of Measure: percentage saturation
5.7
(4.3 to 7.5)
4.1
(2.9 to 5.3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Calibration Validation
Hide Arm/Group Description Initial group of subjects on whom the test algorithm is developed. Group of subjects in whom the final algorithm is tested.
All-Cause Mortality
Calibration Validation
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Calibration Validation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/11 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Calibration Validation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/11 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr David MacLeod
Organization: Duke University Medical Center
Phone: 919-812-3201
Responsible Party: David MacLeod, Duke University
ClinicalTrials.gov Identifier: NCT01762722     History of Changes
Other Study ID Numbers: Pro00018006
First Submitted: February 17, 2012
First Posted: January 8, 2013
Results First Submitted: March 6, 2013
Results First Posted: April 16, 2013
Last Update Posted: April 16, 2013