Evaluation of Non-Invasive Hemoglobin in Trauma Patients

Not Applicable

Completed

• Conditions: Trauma
• Interventions: Device: Radical-7 Pulse CO-Oximeter and sensor

• Registration Number: NCT03123328
• Lead Sponsor: Masimo Corporation

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2016-06-30
• Primary Completion: 2017-03-25
• Study Completion: 2017-03-25
• Study First Submitted: 2017-04-14
• Study First Submitted QC: 2017-04-19
• Study First Posted: 2017-04-21
• Disposition First Submitted: 2018-02-14
• Disposition First Submitted QC: 2018-02-27
• Disposition First Posted: 2018-03-06
• Results First Submitted: 2019-05-03
• Status Verified: 2021-03
• Results First Submitted QC: 2021-03-31
• Last Update Submitted: 2021-03-31
• Results First Posted: 2021-04-27
• Last Update Posted: 2021-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 380

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test Subjects	Radical-7 Pulse CO-Oximeter and sensor	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.

Primary Outcome Measures

Name	Time	Method
SpHb's Ability to Detect Critical Drops	Up to 24 hours.	The ability of noninvasive continuous total hemoglobin (SpHb) to detect critical drops in arterial or venous hemoglobin values, calculated using chi-squared analysis.

Trial Locations

Locations (1)

University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States