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Trial record 37 of 620 for:    oximeter

Evaluation of Non-Invasive Hemoglobin in Trauma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03123328
Recruitment Status : Completed
First Posted : April 21, 2017
Last Update Posted : March 6, 2018
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Trauma Device: Radical-7 Pulse CO-Oximeter and sensor Not Applicable

Detailed Description:
Single-arm study that evaluates noninvasive hemoglobin testing as a method of identifying bleeding patients sooner than standard of care by identifying critical drops between laboratory samples.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 380 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of Non-Invasive Hemoglobin in Trauma Patients Using FDA-Cleared Masimo Pulse CO-Oximeter
Actual Study Start Date : June 30, 2016
Actual Primary Completion Date : March 25, 2017
Actual Study Completion Date : March 25, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Test Subjects
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
Noninvasive device that measures hemoglobin.

Primary Outcome Measures :
  1. SpHb Accuracy of Sensor [ Time Frame: Up to 24 hours. ]
    Accuracy will be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square error (Arms) value.

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03123328

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United States, Texas
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
Masimo Corporation

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Responsible Party: Masimo Corporation Identifier: NCT03123328     History of Changes
Other Study ID Numbers: HOLC0001
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Wounds and Injuries