Evaluation of Non-Invasive Hemoglobin in Trauma Patients

NCT03123328 | Completed Results FDA Device

• 1 other identifier: HOLC0001
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Trauma

Outcome Measures

Primary Outcomes (1)

• SpHb's Ability to Detect Critical Drops

  The ability of noninvasive continuous total hemoglobin (SpHb) to detect critical drops in arterial or venous hemoglobin values, calculated using chi-squared analysis.

  Up to 24 hours.

Study Arms (1)

Test Subjects

EXPERIMENTAL

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.

Device: Radical-7 Pulse CO-Oximeter and sensor

Interventions

Radical-7 Pulse CO-Oximeter and sensor DEVICE

Noninvasive device that measures hemoglobin.

Test Subjects

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Masimo Corporation: lead

Study Sites (1)

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Masimo Corporation

clinicalresearchdept@masimo.com

949-297-7416

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2017
• First Posted: April 21, 2017
• Study Start: June 30, 2016
• Primary Completion: March 25, 2017
• Study Completion: March 25, 2017
• Last Updated: April 27, 2021
• Results First Posted: April 27, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)