Evaluation of Non-Invasive Hemoglobin in Trauma Patients

Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03123328
• Other study ID #: HOLC0001
• Status: Completed
• Phase: N/A
• Start date: June 30, 2016
• Est. completion date: March 25, 2017

Study information

• Verified date: March 2021
• Source: Masimo Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: March 25, 2017
• Est. primary completion date: March 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Trauma
• Wounds and Injuries

Intervention

Device:
• Radical-7 Pulse CO-Oximeter and sensor
Noninvasive device that measures hemoglobin.

Locations

Country	Name	City	State
United States	University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Masimo Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.