Accuracy of Pulse Oximeter With Profound Hypoxia

NCT05693168 | Completed FDA Device

• 1 other identifier: SIBE01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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%.

Conditions

Hypoxia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Comparison of ANNE Limb Sensor pulse oximetry measurements to blood gas analysis

EXPERIMENTAL

Device: ANNE Limb Sensor

Interventions

ANNE Limb Sensor DEVICE

Pulse Oximeter

Comparison of ANNE Limb Sensor pulse oximetry measurements to blood gas analysis

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sibel Health Inc.: lead

Study Sites (1)

Hypoxia Research Laboratory Department of Anesthesia and Perioperative Care University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2022
• First Posted: January 20, 2023
• Study Start: June 23, 2021
• Primary Completion: June 24, 2021
• Study Completion: June 24, 2021
• Last Updated: January 20, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)