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Completed

NCT Number: NCT03123328

Evaluation of Non-Invasive Hemoglobin in Trauma Patients

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

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Key information

Conditions

Trauma Wounds and Injuries

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Radical-7 Pulse CO-Oximeter and sensor

Device

Noninvasive device that measures hemoglobin.

Primary outcomes

  1. SpHb's Ability to Detect Critical Drops

    Time frame: Up to 24 hours.

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

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Masimo Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 21, 2017
Registry last updated
Apr 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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