Status:
COMPLETED
SpO2 Accuracy of Noninvasive Disposable Pulse Oximeter Sensor
Lead Sponsor:
Stryker Sustainability Solutions
Collaborating Sponsors:
University of California, San Francisco
Conditions:
Healthy
Hypoxia
Eligibility:
All Genders
18-55 years
Phase:
NA
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 compar...
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 oximete...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 20 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05245526
Start Date
January 19 2022
End Date
January 20 2022
Last Update
March 20 2023
Active Locations (1)
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1
UCSF Hypoxia Research Laboratory
San Francisco, California, United States, 94133