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.

Study Overview

• Status: Completed
• Conditions: Healthy; Hypoxia
• Intervention / Treatment: Device: STRYKER SUSTAINABILITY SOLUTIONS PULSE OXIMETERS

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94133
      • UCSF Hypoxia Research Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy adult participants; All participants are enrolled in the test group and receive the noninvasive adhesive reprocessed pulse oximeter sensors	Device: STRYKER SUSTAINABILITY SOLUTIONS PULSE OXIMETERS; Reprocessed noninvasive pulse oximeters; 1859 & 2329; MAX-A & MAX-N

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Stryker Sustainability Solutions
• Collaborators: University of California, San Francisco
• Investigators: Principal Investigator: Philip E Bickler, MD, PhD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2021
• Primary Completion (Actual): November 3, 2021
• Study Completion (Actual): November 3, 2021

Study Registration Dates

• First Submitted: November 23, 2021
• First Submitted That Met QC Criteria: November 23, 2021
• First Posted (Actual): December 2, 2021

Study Record Updates

• Last Update Posted (Actual): December 21, 2022
• Last Update Submitted That Met QC Criteria: November 29, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: CRD10302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Data to be used by Sponsor only

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No