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Accuracy of Noninvasive Pulse Oximeter Sensor (Rainbow DCI)

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ClinicalTrials.gov Identifier: NCT03124823
Recruitment Status : Completed
First Posted : April 24, 2017
Results First Posted : July 28, 2017
Last Update Posted : July 28, 2017
Sponsor:
Information provided by (Responsible Party):
Masimo Corporation

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Healthy
Intervention Device: Rainbow DCI Sensor
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Test Subject
Hide Arm/Group Description All subjects are enrolled into the test group and all subjects received the Rainbow DCI Sensor
Period Title: Overall Study
Started 11
Completed 11
Not Completed 0
Arm/Group Title Test Subject
Hide Arm/Group Description All subjects are enrolled into the test group and all subjects received the Rainbow DCI Sensor
Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
24-43 years Number Analyzed 11 participants
11
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
4
  36.4%
Male
7
  63.6%
1.Primary Outcome
Title Accuracy of Sensor by Arms Calculation
Hide Description Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value. In order to obtain the Arms value, the blood oxygen saturation measurement is subtracted from the pulse oximeter oxygen saturation measurement for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.
Time Frame 1-5 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Test Subject
Hide Arm/Group Description:
All subjects are enrolled into the test group and all subjects received the Rainbow DCI Sensor
Overall Number of Participants Analyzed 11
Overall Number of Units Analyzed
Type of Units Analyzed: Data points
598
Measure Type: Number
Unit of Measure: % of oxygen saturated hemoglobin
1.6
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Test Subject
Hide Arm/Group Description All subjects are enrolled into the test group and all subjects received the Rainbow DCI Sensor
All-Cause Mortality
Test Subject
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Test Subject
Affected / at Risk (%)
Total   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%
Test Subject
Affected / at Risk (%)
Total   0/11 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Tala Harake
Organization: Masimo
Responsible Party: Masimo Corporation
ClinicalTrials.gov Identifier: NCT03124823     History of Changes
Other Study ID Numbers: TR29866-TP17699A
First Submitted: April 14, 2017
First Posted: April 24, 2017
Results First Submitted: May 8, 2017
Results First Posted: July 28, 2017
Last Update Posted: July 28, 2017