Accuracy of Pulse Oximeters With Profound Hypoxia

NCT05322382 | Completed

• 1 other identifier: 008_SPO_CV_OS_USF
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This project aims to test the accuracy of pulse oximeters during mild, moderate, and severe hypoxia, i.e., a range of arterial HbO2 saturation from 100 down to 70%. A typical study will include at least ten subjects (at least 200 necessary data points to meet the ISO 80601-2-61:2017).

Conditions

SpO2

Outcome Measures

Primary Outcomes (1)

• Accuracy of pulse oximeter with profound hypoxia

  Perform accurate measurement of a range of arterial HbO2 saturation from 100 to down to 70% during mild, moderate, and severe hypoxia.

  2 days

Study Arms (1)

Single

EXPERIMENTAL

Subjects undergo an interventional procedure and non-invasive measurements of SpO2.

Procedure: A-line

Interventions

A-line PROCEDURE

Subjects breathe air mixtures containing reduced amounts of oxygen to produce the desired level of hypoxemia.

Also known as: Hypoxemia

Single

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CardiacSense Ltd.: lead

Study Sites (1)

University of California at San Francisco

San Francisco, California, 94143, United States

Location

Study Officials

• Philip Bickler, MD

  UCSF Hypoxia Lab

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: April 11, 2022
• Study Start: June 2, 2021
• Primary Completion: June 3, 2021
• Study Completion: June 3, 2021
• Last Updated: April 18, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)