Accuracy of Pulse Oximeter With Profound Hypoxia

Clinical evaluation of the accuracy of SpO2 measurements with the ANNE Limb Sensor compared to blood gas analysis in healthy, adult subjects. Hypoxia is induced in patients to different and stable levels of SaO2 over the range of 70-100%.

Study Overview

• Status: Completed
• Conditions: Hypoxia
• Intervention / Treatment: Device: ANNE Limb Sensor

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • Hypoxia Research Laboratory Department of Anesthesia and Perioperative Care University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The subject is male or female, between the ages of 18 and 55 years.
• 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:

• 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 has 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
• Th 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Comparison of ANNE Limb Sensor pulse oximetry measurements to blood gas analysis	Device: ANNE Limb Sensor; Pulse Oximeter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ARMS of SpO2 Measurements with ANNE Limb compared to SaO2	Root mean square error between the function blood oxygen saturation (SpO2) provided by the device under test and the blood gas analysis of oxyhemoglobin saturation (SaO2)	1 hour

Collaborators and Investigators

• Sponsor: Sibel Health Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2021
• Primary Completion (Actual): June 24, 2021
• Study Completion (Actual): June 24, 2021

Study Registration Dates

• First Submitted: December 27, 2022
• First Submitted That Met QC Criteria: January 12, 2023
• First Posted (Actual): January 20, 2023

Study Record Updates

• Last Update Posted (Actual): January 20, 2023
• Last Update Submitted That Met QC Criteria: January 12, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: SIBE01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No