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Accuracy of Methemoglobin Measurement of Various Rainbow Pulse Oximeter Sensors

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ClinicalTrials.gov Identifier: NCT03124836
Recruitment Status : Completed
First Posted : April 24, 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: Pulse Oximeter Sensor
Enrollment 28
Recruitment Details  
Pre-assignment Details  
Arm/Group Title R2-25 Sensor
Hide Arm/Group Description

All subjects will be enrolled in the test group and will receive R2-25 Pulse Oximeter Sensor

Pulse Oximeter Sensor

Period Title: Overall Study
Started 28
Completed 28
Not Completed 0
Arm/Group Title R2-25 Sensor
Hide Arm/Group Description

All subjects will be enrolled in the test group and will receive R2-25 Pulse Oximeter Sensor

Pulse Oximeter Sensor

Overall Number of Baseline Participants 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
<=18 years
0
   0.0%
Between 18 and 65 years
28
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Female
10
  35.7%
Male
18
  64.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 28 participants
28
1.Primary Outcome
Title Accuracy of Methemoglobin Measurement by Arms Calculation
Hide Description Accuracy willl be determined by comparing the noninvasive blood methemoglobin measurement (expressed as a percentage of total hemoglobin) 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 sample methemoglobin value is subtracted from the pulse oximeter methemoglobin value 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title R2-25 Sensor
Hide Arm/Group Description:

All subjects will be enrolled in the test group and will receive R2-25 Pulse Oximeter Sensor

Pulse Oximeter Sensor

Overall Number of Participants Analyzed 28
Measure Type: Number
Unit of Measure: percentage of total hemoglobin
0.48
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title R2-25 Sensor
Hide Arm/Group Description

All subjects will be enrolled in the test group and will receive R2-25 Pulse Oximeter Sensor

Pulse Oximeter Sensor

All-Cause Mortality
R2-25 Sensor
Affected / at Risk (%)
Total   0/28 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
R2-25 Sensor
Affected / at Risk (%)
Total   0/28 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
R2-25 Sensor
Affected / at Risk (%)
Total   0/28 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
Layout table for Results Point of Contact information
Name/Title: Vikram Ramakanth
Organization: Masimo
EMail: clinicalresearchdept@masimo.com
Layout table for additonal information
Responsible Party: Masimo Corporation
ClinicalTrials.gov Identifier: NCT03124836     History of Changes
Other Study ID Numbers: TR19427-BICK0001
First Submitted: April 14, 2017
First Posted: April 24, 2017
Results First Submitted: May 8, 2017
Results First Posted: July 27, 2017
Last Update Posted: July 27, 2017