Clinical trial NCT05141500: SpO2 Accuracy of Noninvasive Pulse Oximeter Sensor
Official title: SpO2 Accuracy of Noninvasive Pulse Oximeter Sensor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Hypoxia
Lead sponsor: Stryker Sustainability Solutions
Sponsor class: INDUSTRY
Collaborators: name: University of California, San Francisco
First posted: 2021-12-02
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants will be in a reclined position for the study. Reference sensors will be placed on each participant to evaluate the SpO2 accuracy and performance. Sensors may be placed on non-adjacent fingers to prevent optical crosstalk. Simultaneous data collection will be set up for devices under test. The data from the test devices will be collected by the sponsor or trained UCSF staff. Data will be collected for 1-2 second intervals data analysis. The SpO2 accuracy of the test devices will be evaluated over the oxygen saturation range between 70-100%.
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Accuracy of Sensor by Arms Calculation
timeFrame: 1-2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Hypoxia Research Laboratory
state: California
Study officials:
affiliation: University of California, San Francisco
name: Philip E Bickler, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: