EmbracePlus SpO2 Accuracy Validation

Oximetry Clinical Trial

Official title:

Accuracy of Pulse Oximeters With Profound Hypoxia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04964609
• Other study ID #: CIP-4
• Secondary ID: EMPA01
• Status: Completed
• Phase: N/A
• Start date: June 16, 2021
• Est. completion date: November 21, 2022

Study information

• Verified date: November 2022
• Source: Empatica, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: November 21, 2022
• Est. primary completion date: November 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Oximetry

Intervention

Device:
• EmbracePlus
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.

Locations

Country	Name	City	State
United States	Hypoxia Research Laboratory Department of Anesthesia and Perioperative Care University of California	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Empatica, Inc.	Empatica Srl

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SpO2 Accuracy	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	Through study completion, 3 months average