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SpO2 Accuracy of Noninvasive Disposable Pulse Oximeter Sensor

Primary Purpose

Healthy, Hypoxia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
STRYKER SUSTAINABILITY SOLUTIONS PULSE OXIMETERS
Sponsored by
Stryker Sustainability Solutions
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Healthy

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UCSF Hypoxia Research Laboratory

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Healthy adult participants

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 8, 2022
Last Updated
February 21, 2023
Sponsor
Stryker Sustainability Solutions
Collaborators
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT05245526
Brief Title
SpO2 Accuracy of Noninvasive Disposable Pulse Oximeter Sensor
Official Title
Validate SpO2 Accuracy of Noninvasive Stryker Disposable Pulse Oximeter Sensors With Hypoxia at Rest
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 19, 2022 (Actual)
Primary Completion Date
January 20, 2022 (Actual)
Study Completion Date
January 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stryker Sustainability Solutions
Collaborators
University of California, San Francisco

4. Oversight

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.
Yes
Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Hypoxia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy adult participants
Arm Type
Experimental
Arm Description
All participants are enrolled in the test group and receive the noninvasive adhesive reprocessed pulse oximeter sensors.
Intervention Type
Device
Intervention Name(s)
STRYKER SUSTAINABILITY SOLUTIONS PULSE OXIMETERS
Intervention Description
Reprocessed noninvasive pulse oximeter sensors.
Primary Outcome Measure Information:
Title
Accuracy of Sensor by Arms Calculation
Description
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.
Time Frame
1-2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip E Bickler, MD, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Hypoxia Research Laboratory
City
San Francisco
State/Province
California
ZIP/Postal Code
94133
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data to be used by Sponsor only.

Learn more about this trial

SpO2 Accuracy of Noninvasive Disposable Pulse Oximeter Sensor

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