Status:
COMPLETED
The Sunrise SpO2 and Pulse Rate Accuracy Validation Study
Lead Sponsor:
Sunrise
Conditions:
Validation Study
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the SpO2 accuracy performance of the Sunrise Sensor 2 placed at the tip of the chin during non-motion conditions over the range of 70-100% by comparison to SaO...
Detailed Description
Subjects will be given medical grade mixtures of oxygen and nitrogen to induce stable plateaus across the range of 100% to 70% SaO2. When the reference system's blood saturation stabilizes at an accep...
Eligibility Criteria
Inclusion
- Subjects with positive Allen's test
- Subject must be willing and able to comply with study procedures and duration
- Subject is a non-smoker or who has not smoked within 2 days prior to the study
- 15% of the study population or 2 subjects (whichever is larger) with dark pigmented skin should be included in the study
Exclusion
- Subject is considered as being morbidly obese (defined as BMI \>39.5)
- Females who are pregnant, who are trying to get pregnant, or have a urine test positive for pregnancy on the day of the study
- Subjects with known heart or cardiovascular conditions
- Subjects with other known health condition (diabetes, thyroid disease, kidney disease/chronic renal impairment, history of seizures (except childhood febrile seizures) or epilepsy, or unexplained syncope, recent history of frequent migraine headaches, recent head injury, cancer/chemotherapy)
Key Trial Info
Start Date :
May 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 21 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05386836
Start Date
May 24 2022
End Date
June 21 2022
Last Update
June 28 2022
Active Locations (1)
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1
Respisom
Namur, Belgium