Evaluation of Non-Invasive Hemoglobin in Trauma Patients

Masimo

Status: Completed

Conditions: Trauma

Treatments: Device: Radical-7 Pulse CO-Oximeter and sensor

Study type: Interventional

Funder types: Industry

Identifiers

NCT03123328

HOLC0001

Details and patient eligibility

About

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

Full description

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

Enrollment: 380 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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380 participants in 1 patient group

Test Subjects

Experimental group

Description:

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.

Treatment:

Device: Radical-7 Pulse CO-Oximeter and sensor