Completed

SpO2 Accuracy of Noninvasive Disposable Pulse Oximeter Sensor With Motion Conditions

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What is being tested

STRYKER SUSTAINABILITY SOLUTIONS PULSE OXIMETERS

Device
Who is being recruted

Hypoxia+1

+ Signs and Symptoms

+ Signs and Symptoms, Respiratory

From 18 to 55 Years
+19 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Interventional
Study Start: February 2022
See protocol details

Summary

Principal SponsorStryker Sustainability Solutions
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 2, 2022

Actual date on which the first participant was enrolled.

In this study, the level of oxygen within the blood will be reduced in a controlled manner by reducing the concentration of oxygen the participant breathes. The accuracy of a noninvasive pulse oximeter sensor will be assessed by comparison to the oxygen saturation measurements from a laboratory blood gas analyzer. It is required that the Accuracy Root Mean Square (ARMS) performance of the Stryker pulse oximetry sensors will meet a specification of +/-3% or better in motion conditions for the range of 70 - 100% SaO2 (typically, saturation is determined once with air breathing and then at one of 6 levels, e.g. 94%, 90%, 85%, 80%, 75% and 70% saturation for about 30-60 seconds at each level), thereby demonstrating an acceptable SpO2 accuracy performance specification. Motion is defined as controlled rubbing or tapping of the subject's fingers in a 2-4 Hz or random sine motion with 2-3 cm amplitude.

Official TitleSpO2 Accuracy of Noninvasive Disposable Pulse Oximeter Sensor With Motion Conditions
NCT05264116
Principal SponsorStryker Sustainability Solutions
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

12 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

HypoxiaSigns and SymptomsSigns and Symptoms, RespiratoryPathological Conditions, Signs and Symptoms

Criteria

3 inclusion criteria required to participate
Good general health with no evidence of pre-existing medical problems
Fluent in both written and spoken English
Must be able to review informed consent and is willing to comply with study procedures
16 exclusion criteria prevent from participating
Obesity (BMI >30)
Known history of heart disease, lung disease, kidney or liver disease
Prior diagnosis of asthma, sleep apnea, or use of CPAP
Diabetes
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
All participants are enrolled in the test group and receive the noninvasive adhesive reprocessed pulse oximeter sensors.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

UCSF Hypoxia Research Laboratory

San Francisco, United StatesOpen UCSF Hypoxia Research Laboratory in Google Maps
CompletedOne Study Center