SpO2 Accuracy of Noninvasive Pulse Oximeter Sensor

The purpose of this clinical study is to validate the SpO2 accuracy of the Stryker Sustainability Solutions pulse oximetry sensors during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. The end goal is to provide supporting documentation for the SpO2 accuracy validation of the reprocessed sensors.

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Key information

Conditions

Healthy Hypoxia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSF Hypoxia Research Laboratory

San Francisco, California, 94133, United States

About this study

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 non-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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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
Clotting disorder
Hemoglobinopathy or history of anemia that in the opinion of the investigators would make them unsuitable for study participation
Any serious systemic illness
Current smoker
Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigator would interfere with the sensors working correctly
History of fainting or vasovagal response
History of sensitivity to local anesthesia
Prior diagnosis of Raynaud's disease
Unacceptable collateral circulation based on exam by investigators (Allen's test)
Pregnant, lactating, or trying to get pregnant
Unable or unwilling to provide informed consent, or unable or unwilling to comply with study procedures
Any other condition which in the opinion of the investigators would make them unsuitable for the study

Treatment and study plan

STRYKER SUSTAINABILITY SOLUTIONS PULSE OXIMETERS

Device

Reprocessed noninvasive pulse oximeters

1859 & 2329
MAX-A & MAX-N

Primary outcomes

Accuracy of Sensor by Arms Calculation

Time frame: 1-2 hours

Percentage of SpO2 (oxygen saturation by pulse oximetry) measured by the Reprocessed Oximeter pulse oximetry sensors during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. Accuracy root mean square (ARMS) between measured SpO2 and reference SaO2 (arterial oxygen saturation) must meet the 3% specification for each reprocessed pulse oximetry sensor style. Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square error (Arms) value. Standard deviation of the differences is computed as the precision. Square root of the sum of the squares of bias and precision is computed as the Arms Error value.

Sponsors and collaborators

Lead sponsor

Stryker Sustainability Solutions

Industry

Collaborators

University of California, San Francisco

Registry information

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2021
First posted: Dec 2, 2021
Registry last updated: Dec 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed