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Rainbow DCI vs. R1-25 Sensor SpHb Sub-Range Performance Equivalence

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ClinicalTrials.gov Identifier: NCT03157232
Recruitment Status : Completed
First Posted : May 17, 2017
Results First Posted : July 27, 2017
Last Update Posted : July 27, 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 and R1-25 sensor
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Test Group
Hide Arm/Group Description All subjects are enrolled into the test group and all subjects received both the Rainbow DCI and R1-25 sensor.
Period Title: Overall Study
Started 18
Completed 18
Not Completed 0
Arm/Group Title Test Group
Hide Arm/Group Description All subjects are enrolled into the test group and all subjects received both the Rainbow DCI and R1-25 sensor.
Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
26-65 years Number Analyzed 18 participants
18
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
6
  33.3%
Male
12
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants
18
1.Primary Outcome
Title Sub-Range Performance Equivalence of Rainbow DCI and R1-25 Sensors by ARMS Calculation
Hide Description Sub-range performance equivalence was determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter sensor to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square (Arms) error value.In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from the pulse oximeter hemoglobin value for a number of samples, the average of this difference is computed as the bias. The standard deviation of these 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 per subject
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Test Group
Hide Arm/Group Description:
All subjects are enrolled into the test group and all subjects received both the Rainbow DCI and R1-25 sensor.
Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: g/dL
Rainbow DCI 1.2
R1-25 1.2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Test Group
Hide Arm/Group Description All subjects are enrolled into the test group and all subjects received both the Rainbow DCI and R1-25 sensor.
All-Cause Mortality
Test Group
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Test Group
Affected / at Risk (%)
Total   0/18 (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 Group
Affected / at Risk (%)
Total   0/18 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Tala Harake
Organization: Masimo
EMail: studies@masimo.com
Layout table for additonal information
Responsible Party: Masimo Corporation
ClinicalTrials.gov Identifier: NCT03157232     History of Changes
Other Study ID Numbers: TR18695-TP14480
First Submitted: April 14, 2017
First Posted: May 17, 2017
Results First Submitted: May 19, 2017
Results First Posted: July 27, 2017
Last Update Posted: July 27, 2017