Status:
COMPLETED
SpO2 Accuracy of Noninvasive Pulse Oximeter Sensor With Motion Conditions
Lead Sponsor:
Stryker Sustainability Solutions
Conditions:
Healthy
Hypoxia
Eligibility:
All Genders
18-50 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 motion conditions over the range of 70 -100% SaO2 as compared ...
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 study volunteer breathes. The accuracy of a noninvasive pulse oxi...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- The subject has any other condition, which in the opinion of the investigators would make them unsuitable for the study
Key Trial Info
Start Date :
May 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 28 2023
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT06149416
Start Date
May 27 2023
End Date
May 28 2023
Last Update
June 6 2025
Active Locations (1)
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1
UCSF Hypoxia Research Laboratory
San Francisco, California, United States, 94133