Evaluation of Non-Invasive Hemoglobin in Trauma Patients

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-03-25

Brief Summary

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

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Detailed Description

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

Conditions

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Trauma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Radical-7 Pulse CO-Oximeter and sensor

Intervention Type DEVICE

Noninvasive device that measures hemoglobin.

Interventions

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Radical-7 Pulse CO-Oximeter and sensor

Noninvasive device that measures hemoglobin.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No