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COMPLETEDNANCT03123328

Evaluation of Non-Invasive Hemoglobin in Trauma Patients

This is a prospective, non-blinded, non-randomized, interventional study of the Masimo pulse oximeter and sensors in a trauma setting

Lead sponsor: Masimo Corporation•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Masimo Corporation

The study aimed to evaluate SpHb's ability to detect critical drops in a trauma population

Age

16 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Estimated 16 years of age or older or greater than or equal to 50 kg body weight if age unknown.
•Level 1 (highest trauma activation) status at the time of arrival to emergency department (ED).
•Expected to be admitted to the ICU/IMU for in hospital care.

Exclusion Criteria

•Moribund patients with devastating injuries and expected to die within one hour of ED admission.
•Prisoners, as defined as those who have been directly admitted from a correctional facility (a free living individual who is under police observation as a suspect will remain in the study until hospital discharge).
•Obvious pregnancy in the ED.
•Received greater than 5 minutes of cardiopulmonary resuscitation (CPR) in the pre-arrival or hospital setting.
•Has, on the ring, middle and index fingers of both hands, any of the following: finger deformities, injuries, including burns, scar tissue or infection, or any material that may interfere with sensor application or trans-illumination of the site.
•Has significant bilateral trauma to the arms or forearms.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: April 27, 2021Terms

Trial snapshot

StatusCOMPLETED

PhaseNA

Enrollment380

Start dateJun 2016

Last updatedApr 27, 2021

Condition

Locations shown

University of Texas Health Science Center at Houston

Houston, Texas

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 27, 2021Data synced to Clareo: May 3, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions