Evaluation of Non-Invasive Hemoglobin in Trauma Patients



Status:Completed
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:16 - Any
Updated:4/17/2018
Start Date:June 30, 2016
End Date:March 25, 2017

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Evaluation of Non-Invasive Hemoglobin in Trauma Patients Using FDA-Cleared Masimo Pulse CO-Oximeter

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

Single-arm study that evaluates noninvasive hemoglobin testing as a method of identifying
bleeding patients sooner than standard of care by identifying critical drops between
laboratory samples.

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.
We found this trial at
1
site
7000 Fannin St
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
?
mi
from
Houston, TX
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