Spot-Check Noninvasive Hemoglobin (SpHb) Repeatability and Reproducibility
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|ClinicalTrials.gov Identifier: NCT03128853|
Recruitment Status : Completed
First Posted : April 25, 2017
Last Update Posted : April 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Anemia Healthy||Device: Pulse CO-Oximeter and sensor||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||57 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Spot-Check Noninvasive Hemoglobin (SpHb) Repeatability and Reproducibility|
|Actual Study Start Date :||October 31, 2016|
|Actual Primary Completion Date :||November 15, 2016|
|Actual Study Completion Date :||November 15, 2016|
Experimental: Test subjects
Each subject receives a Pulse CO-Oximeter and sensor that will measure hemoglobin repeatedly in order to compare those measurements against a blood sample reference.
Device: Pulse CO-Oximeter and sensor
Noninvasive Pulse CO-Oximeter device and sensor are used to evaluate SpHb.
- Repeatability and reproducibility of CO-oximeter and sensor [ Time Frame: 120 minutes ]The Repeatability and Reproducibility of the sensor will be assessed by varying the testing conditions (operator/device, finger, subject, and repetition) to determine the device and sensor's precision in SpHb measurements.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03128853
|United States, California|
|Masimo Clinical Laboratory|
|Irvine, California, United States, 92618|
|United States, North Carolina|
|Charlotte, North Carolina, United States|