Back to resultsEvaluation of Non-Invasive Hemoglobin in Trauma Patients
Primary Purpose
Trauma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Radical-7 Pulse CO-Oximeter and sensor
Sponsored by
About this trial
This is an interventional other trial for Trauma
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.
Sites / Locations
- University of Texas Health Science Center at Houston
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Test Subjects
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03123328
Brief Title
Evaluation of Non-Invasive Hemoglobin in Trauma Patients
Official Title
Evaluation of Non-Invasive Hemoglobin in Trauma Patients Using FDA-Cleared Masimo Pulse CO-Oximeter
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
June 30, 2016 (Actual)
Primary Completion Date
March 25, 2017 (Actual)
Study Completion Date
March 25, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Masimo Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
380 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test Subjects
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Radical-7 Pulse CO-Oximeter and sensor
Intervention Description
Noninvasive device that measures hemoglobin.
Primary Outcome Measure Information:
Title
SpHb's Ability to Detect Critical Drops
Description
The ability of noninvasive continuous total hemoglobin (SpHb) to detect critical drops in arterial or venous hemoglobin values, calculated using chi-squared analysis.
Time Frame
Up to 24 hours.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Non-Invasive Hemoglobin in Trauma Patients
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