SpO2 Accuracy of Noninvasive Disposable Pulse Oximeter Sensor With Motion Conditions

Stryker

Status: Completed

Conditions: Healthy; Hypoxia

Treatments: Device: STRYKER SUSTAINABILITY SOLUTIONS PULSE OXIMETERS

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05264116

CRD10318

Details and patient eligibility

About

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.

Full 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 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. Motion is defined as controlled rubbing or tapping of the subject's fingers in a 2-4 Hz or random sine motion with 2-3 cm amplitude.

Enrollment: 12 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Healthy adult participants

Experimental group

Description:

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

Treatment:

Device: STRYKER SUSTAINABILITY SOLUTIONS PULSE OXIMETERS