N/A
N=380
Evaluation of Non-Invasive Hemoglobin in Trauma Patients
Trauma
Bottom Line
View on ClinicalTrials.gov: NCT03123328 ↗Enrolled (actual)
380
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: SpHb's Ability to Detect Critical Drops
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Radical-7 Pulse CO-Oximeter and sensor (Device)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Masimo Corporation
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY SpHb's Ability to Detect Critical Drops |
— | — |
Summary
This is a prospective, non-blinded, non-randomized, interventional study of the Masimo pulse oximeter and sensors in a trauma setting
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03123328). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.