SpO2 Accuracy of Noninvasive Pulse Oximeter Sensor

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

STRYKER SUSTAINABILITY SOLUTIONS PULSE OXIMETERS

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

NCT ID

NCT05141500

First Posted

November 23, 2021

Last Updated

November 29, 2022

Sponsor

Stryker Sustainability Solutions

Collaborators

University of California, San Francisco

1. Study Identification

Unique Protocol Identification Number

NCT05141500

Brief Title

SpO2 Accuracy of Noninvasive Pulse Oximeter Sensor

Official Title

SpO2 Accuracy of Noninvasive Pulse Oximeter Sensor

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Completed

Study Start Date

November 2, 2021 (Actual)

Primary Completion Date

November 3, 2021 (Actual)

Study Completion Date

November 3, 2021 (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.

No

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 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.

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

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%.

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 oximeters 1859 & 2329 MAX-A & MAX-N

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

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

Healthy, Hypoxia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial