SpO2 Accuracy of Noninvasive Disposable Pulse Oximeter Sensor With Motion Conditions

NCT05264116 | Completed Results FDA Device

• 1 other identifier: CRD10318
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical study is to validate the SpO2 accuracy of the Stryker Sustainability Solutions pulse oximetry sensors during 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.

Conditions

Healthy; Hypoxia

Outcome Measures

Primary Outcomes (1)

• Accuracy of Sensor by Arms Calculation Under Motion Conditions

  Percentage of SpO2 (oxygen saturation by pulse oximetry) measured by the Reprocessed Oximeter pulse oximetry sensors during 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

Study Arms (1)

Healthy adult participants

EXPERIMENTAL

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

Device: STRYKER SUSTAINABILITY SOLUTIONS PULSE OXIMETERS

Interventions

STRYKER SUSTAINABILITY SOLUTIONS PULSE OXIMETERS DEVICE

Reprocessed noninvasive pulse oximeter sensors.

Healthy adult participants

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stryker Sustainability Solutions: lead
• University of California, San Francisco: collaborator

Study Sites (1)

UCSF Hypoxia Research Laboratory

San Francisco, California, 94133, United States

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Monique Ketcher
• Organization: Stryker Sustainability Solutions

monique.ketcher@stryker.com

602-354-0917

Study Officials

• Philip E Bickler, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: March 3, 2022
• Study Start: February 2, 2022
• Primary Completion: February 3, 2022
• Study Completion: February 3, 2022
• Last Updated: May 20, 2025
• Results First Posted: March 10, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)