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Accuracy of Hemoglobin Measurement for Various Rainbow Pulse Oximeter Sensors

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ClinicalTrials.gov Identifier: NCT03124966
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: Pulse Oximeter sensor
Enrollment 118
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Noninvasive Hemoglobin Sensor
Hide Arm/Group Description All subjects are enrolled into the test group and all will receive the pulse oximeter sensor.
Period Title: Overall Study
Started 118
Completed 118
Not Completed 0
Arm/Group Title Noninvasive Hemoglobin Sensor
Hide Arm/Group Description All subjects are enrolled into the test group and all will receive the pulse oximeter sensor.
Overall Number of Baseline Participants 118
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 118 participants
<=18 years
0
   0.0%
Between 18 and 65 years
118
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 118 participants
Female
40
  33.9%
Male
78
  66.1%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 118 participants
118
1.Primary Outcome
Title Accuracy of Sensor 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.
Time Frame 1-3 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Noninvasive Hemoglobin Sensor
Hide Arm/Group Description:
All subjects are enrolled into the test group and all will receive the pulse oximeter sensor.
Overall Number of Participants Analyzed 118
Measure Type: Number
Unit of Measure: g/dL
0.96
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Noninvasive Hemoglobin Sensor
Hide Arm/Group Description All subjects are enrolled into the test group and all will receive the pulse oximeter sensor.
All-Cause Mortality
Noninvasive Hemoglobin Sensor
Affected / at Risk (%)
Total   0/118 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Noninvasive Hemoglobin Sensor
Affected / at Risk (%)
Total   0/118 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Noninvasive Hemoglobin Sensor
Affected / at Risk (%)
Total   0/118 (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
Name/Title: Vikram Ramakanth
Organization: Masimo
Responsible Party: Masimo Corporation
ClinicalTrials.gov Identifier: NCT03124966     History of Changes
Other Study ID Numbers: TR19443-56044
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