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OpenTrials
Completed

NCT Number: NCT04964609

EmbracePlus SpO2 Accuracy Validation

The aim of this study is to test the accuracy of EmbracePlus computed SpO2 during mild, moderate and severe hypoxia (a lower-than-normal concentration of oxygen in arterial blood); ie, a range of arterial HbO2 saturations from 100 to down to 70%. This is done by comparing the reading of the the subject device during brief, steady state hypoxia with a gold-standard measurement of blood oxyhemoglobin (hemoglobin carrying oxygen) saturation, that is arterial blood sample processed in a laboratory.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hypoxia Research Laboratory Department of Anesthesia and Perioperative Care University of California

San Francisco, California, 94143, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • The subject is male or female, aged ≥18 and <50.
  • The subject is in good general health with no evidence of any medical problems.
  • The subject is fluent in both written and spoken English.
  • The subject has provided informed consent and is willing to comply with the study procedures.

Exclusion criteria

  • The subject is obese (BMI>30).
  • The subject has a known history of heart disease, lung disease, kidney or liver disease.
  • Diagnosis of asthma, sleep apnea, or use of CPAP.
  • Subject has diabetes.
  • Subject has a clotting disorder.
  • The subject a hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation.
  • The subject has any other serious systemic illness.
  • The subject is a current smoker.
  • Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly.
  • The subject has a history of fainting or vasovagal response.
  • The subject has a history of sensitivity to local anesthesia.
  • The subject has a diagnosis of Raynaud's disease.
  • The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).
  • The subject is pregnant, lactating or trying to get pregnant.
  • The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures.
  • The subject has any other condition, which in the opinion of the investigators' would make them unsuitable for the study.

Treatment and study plan

EmbracePlus

Device

A device intended for use by researchers and healthcare professionals for continuous collection of physiological parameters in home and healthcare settings.

Parallel blood gas analysis to determine oxyhemoglobin saturation (SaO2) using an ABL-90 multi-wavelength oximeter.

Primary outcomes

  1. SpO2 Accuracy

    Time frame: Through study completion, 3 months average

    SpO2 as measured by the subject device during periods of low motion will be compared to the oxyhemoglobin saturation (SaO2) as measured by direct oximetry with a Radiometer ABL-90 multi-wavelength oximeter

Sponsors and collaborators

Lead sponsor

Empatica, Inc.

Industry

Collaborators

  • Empatica Srl

Registry information

Official study title

Accuracy of Pulse Oximeters With Profound Hypoxia

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 16, 2021
Registry last updated
Nov 25, 2022

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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