EmbracePlus SpO2 Accuracy Validation

NCT ID: NCT04964609

Last Updated: 2022-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-16
• Study Completion Date: 2022-11-21

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.

Conditions

Oximetry

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Single Arm

Comparison of EmbracePlus SpO2 readings with arterial blood saturation laboratory analysis in the same subject

Group Type: EXPERIMENTAL

EmbracePlus

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Empatica Srl

UNKNOWN

Sponsor Role: collaborator

Empatica, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

San Francisco, California, United States

Countries

United States

References

Gerboni G, Comunale G, Chen W, Lever Taylor J, Migliorini M, Picard R, Cruz M, Regalia G. Prospective clinical validation of the Empatica EmbracePlus wristband as a reflective pulse oximeter. Front Digit Health. 2023 Dec 4;5:1258915. doi: 10.3389/fdgth.2023.1258915. eCollection 2023.

Reference Type: DERIVED

PMID: 38111608 (View on PubMed)

Other Identifiers

EMPA01

Identifier Type: OTHER

Identifier Source: secondary_id

CIP-4

Identifier Type: -

Identifier Source: org_study_id