SpO2 Accuracy of Noninvasive Disposable Pulse Oximeter Sensor

Healthy Clinical Trial

Official title:

Validate SpO2 Accuracy of Noninvasive Stryker Disposable Pulse Oximeter Sensors With Hypoxia at Rest

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05245526
• Other study ID #: CRD10298
• Status: Completed
• Phase: N/A
• Start date: January 19, 2022
• Est. completion date: January 20, 2022

Study information

• Verified date: February 2023
• Source: Stryker Sustainability Solutions
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 3 levels, e.g. 95%, 85%, and 75% saturation for about 30-60 seconds at each level), thereby demonstrating an acceptable SpO2 accuracy performance specification.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 20, 2022
• Est. primary completion date: January 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Hypoxia

Intervention

Device:
• STRYKER SUSTAINABILITY SOLUTIONS PULSE OXIMETERS
Reprocessed noninvasive pulse oximeter sensors.

Locations

Country	Name	City	State
United States	UCSF Hypoxia Research Laboratory	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Stryker Sustainability Solutions	University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of Sensor by Arms Calculation	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.	1-2 hours