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Accuracy of Noninvasive Hemoglobin Pulse Oximeter (Rainbow Resposable Adhesive Sensors)

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ClinicalTrials.gov Identifier: NCT03124771
Recruitment Status : Completed
First Posted : April 24, 2017
Results First Posted : June 6, 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 Resposable Adhesive Sensors
Enrollment 132

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Rainbow Resposable Adhesive Sensor
Hide Arm/Group Description All subjects are enrolled into the test group and all subjects received the Rainbow Resposable Adhesive Sensor.
Period Title: Overall Study
Started 132
Completed 132
Not Completed 0
Arm/Group Title Rainbow Resposable Adhesive Sensors
Hide Arm/Group Description All subjects are enrolled into the test group and all subjects received the Rainbow Resposable Adhesive Sensor.
Overall Number of Baseline Participants 132
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
18-40 years Number Analyzed 132 participants
132
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 132 participants
Female
65
  49.2%
Male
67
  50.8%
1.Primary Outcome
Title Accuracy of Sensor by Arms Calculation
Hide Description Accuracy willl be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value.
Time Frame 1-5 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rainbow Resposable Adhesive Sensor
Hide Arm/Group Description:
All subjects are enrolled into the test group and all subjects received the Rainbow Resposable Adhesive Sensor.
Overall Number of Participants Analyzed 132
Overall Number of Units Analyzed
Type of Units Analyzed: Data points
1345
Measure Type: Number
Unit of Measure: g/dL
1.0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rainbow Resposable Adhesive Sensor
Hide Arm/Group Description All subjects are enrolled into the test group and all subjects received the Rainbow Resposable Adhesive Sensor.
All-Cause Mortality
Rainbow Resposable Adhesive Sensor
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Rainbow Resposable Adhesive Sensor
Affected / at Risk (%)
Total   0/132 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Rainbow Resposable Adhesive Sensor
Affected / at Risk (%)
Total   0/132 (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: NCT03124771     History of Changes
Other Study ID Numbers: TR23394-TP16171
First Submitted: April 14, 2017
First Posted: April 24, 2017
Results First Submitted: May 8, 2017
Results First Posted: June 6, 2017
Last Update Posted: July 27, 2017