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Comparison of Noninvasive Hemoglobin Disposable Sensors

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ClinicalTrials.gov Identifier: NCT03125031
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 Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Healthy
Interventions Device: Rainbow adhesive adult/pediatric sensor
Device: Rainbow adhesive adult/neonatal sensor
Enrollment 44
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Rainbow Adhesive Adult/Pediatric Sensor Rainbow Adhesive Adult/Neonatal Sensor
Hide Arm/Group Description All subjects are enrolled into the test group and receive the Rainbow adhesive adult/pediatric sensors. All subjects are enrolled into the test group and receive the Rainbow adhesive adult/neonatal sensors.
Period Title: Overall Study
Started 44 44
Completed 44 44
Not Completed 0 0
Arm/Group Title Rainbow Adhesive Adult/Pediatric and Adult/Neonatal Sensors
Hide Arm/Group Description All subjects are enrolled into the test group and receive the Rainbow adhesive sensors (adult/pediatric and adult/neonatal sensors).
Overall Number of Baseline Participants 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
18-38 years Number Analyzed 44 participants
44
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
Female
12
  27.3%
Male
32
  72.7%
1.Primary Outcome
Title Accuracy of Noninvasive Sensors by Arms Calculation
Hide Description Accuracy will 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. The accuracy results from both sensors will be assessed for equivalence
Time Frame 1-5 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group-Sensor 1 Group-Sensor 2
Hide Arm/Group Description:
All subjects are enrolled into the test group and receive the Rainbow adhesive adult/pediatric sensors.
All subjects are enrolled into the test group and receive the Rainbow adhesive adult/neonatal sensors.
Overall Number of Participants Analyzed 44 44
Overall Number of Units Analyzed
Type of Units Analyzed: Data points
691 928
Measure Type: Number
Unit of Measure: g/dL
1.0 1.0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rainbow Adhesive Adult/Pediatric and Adult/Neonatal Sensors
Hide Arm/Group Description All subjects are enrolled into the test group and receive the Rainbow adhesive sensors (adult/pediatric and adult/neonatal).
All-Cause Mortality
Rainbow Adhesive Adult/Pediatric and Adult/Neonatal Sensors
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Rainbow Adhesive Adult/Pediatric and Adult/Neonatal Sensors
Affected / at Risk (%)
Total   0/44 (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 Adhesive Adult/Pediatric and Adult/Neonatal Sensors
Affected / at Risk (%)
Total   0/44 (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: NCT03125031     History of Changes
Other Study ID Numbers: TR26947-TP16847A
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