EmbracePlus SpO2 Accuracy Validation

Not Applicable

Completed

• Conditions: Oximetry
• Interventions: Device: EmbracePlus

• Registration Number: NCT04964609
• Lead Sponsor: Empatica, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-16
• Study First Submitted: 2021-07-06
• Study First Submitted QC: 2021-07-15
• Study First Posted: 2021-07-16
• Status Verified: 2022-11
• Primary Completion: 2022-11-21
• Study Completion: 2022-11-21
• Last Update Submitted: 2022-11-21
• Last Update Posted: 2022-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	EmbracePlus	Comparison of EmbracePlus SpO2 readings with arterial blood saturation laboratory analysis in the same subject

Primary Outcome Measures

Name	Time	Method
SpO2 Accuracy	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

Trial Locations

Locations (1)

Hypoxia Research Laboratory Department of Anesthesia and Perioperative Care University of California; 🇺🇸 San Francisco, California, United States