Evaluation of Non-Invasive Hemoglobin in Trauma Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03123328|
Recruitment Status : Completed
First Posted : April 21, 2017
Last Update Posted : March 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Trauma||Device: Radical-7 Pulse CO-Oximeter and sensor||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||380 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Non-Invasive Hemoglobin in Trauma Patients Using FDA-Cleared Masimo Pulse CO-Oximeter|
|Actual Study Start Date :||June 30, 2016|
|Actual Primary Completion Date :||March 25, 2017|
|Actual Study Completion Date :||March 25, 2017|
Experimental: Test Subjects
Each test subject will receive a Radical-7 Pulse CO-Oximeter and sensor that will remain on the subject for the first 24 hours following ED admission or discharge from the ICU/IMU.
Device: Radical-7 Pulse CO-Oximeter and sensor
Noninvasive device that measures hemoglobin.
- SpHb Accuracy of Sensor [ Time Frame: Up to 24 hours. ]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 error (Arms) value.
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): NCT03123328
|United States, Texas|
|University of Texas Health Science Center at Houston|
|Houston, Texas, United States, 77030|