SpO2 Accuracy of Noninvasive Pulse Oximeter Sensor With Motion Conditions

NCT06149416 | Completed Results FDA Device

• 1 other identifier: CRD10351
• Study Type: interventional
• Target: 11
• 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 during conditions in which the subject is moving. The end goal is to provide supporting documentation for the SpO2 accuracy validation of the reprocessed sensors with motion indications.

Conditions

Healthy; Hypoxia

Outcome Measures

Primary Outcomes (1)

• Accuracy of Sensor by Comparing SpO2 Percent Blood Oxygen Saturation to SaO2 Percent Blood Oxygen Saturation Utilizing Arms Calculation Calculation [Time Frame: 1 - 5 Hours]

  The outcome of this study is the accuracy of the SpO2 (percent oxygen saturation by pulse oximetry) measured by the Reprocessed Oximeter pulse oximetry sensors during motion conditions over the range of 70 - 100% saturation compared to SaO2 (percent oxygen saturation by co-oximetry from blood samples) from arterial blood samples. The accuracy is calculated using the Arms error between measured SpO2 and reference SaO2. The Arms must meet the 3% specification for each reprocessed pulse oximetry sensor style. 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 - 5 hours

Study Arms (1)

Experimental Arms

EXPERIMENTAL

Experimental: Healthy adult participants All participants are enrolled in the test group and receive the noninvasive adhesive reprocessed pulse oximeter sensors

Device: Experimental Masimo RD SET SpO2 Adhesive Sensors

Interventions

Experimental Masimo RD SET SpO2 Adhesive Sensors DEVICE

Masimo RD SET SpO2 Adhesive Sensors, Adult (4000 Adt), Adult \& Neonate (4003 Neo)

Experimental Arms

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The subject is male or female, aged ≥18 and \<50
• The subject is in good general health with no evidence of any medical problems.
• The subject is fluent in both written and spoken English
• The subject has provided informed consent and is willing to comply with the study procedures

You may not qualify if:

• The subject is obese (BMI\>30)
• The subject has a known history of heart disease, lung disease, kidney or liver disease
• Diagnosis of asthma, sleep apnea, or use of CPAP
• Subject has diabetes
• Subject has a clotting disorder
• The subject a hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation
• The subject has any other serious systemic illness
• The subject is a current smoker
• Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators would interfere with the sensors working correctly
• The subject has a history of fainting or vasovagal response
• The subject has a history of sensitivity to local anesthesia
• The subject has a diagnosis of Raynaud's disease
• The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test)
• The subject is pregnant, lactating or trying to get pregnant
• The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures

Sponsors & Collaborators

• Stryker Sustainability Solutions: lead

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: Senior Principal Regulatory Affairs
• Organization: Stryker Sustainability Solutions

moira.barton@stryker.com

5602-410-0204

Study Officials

• Philip Bickler, MD, PhD

  UCSF Hypoxia Research Laboratory

  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: November 20, 2023
• First Posted: November 29, 2023
• Study Start: May 27, 2023
• Primary Completion: May 28, 2023
• Study Completion: May 28, 2023
• Last Updated: June 6, 2025
• Results First Posted: June 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)