Status:
COMPLETED
Accuracy of ScanWatch Pulse Oximeter With Profound Hypoxia
Lead Sponsor:
Withings
Conditions:
Oximetry
Eligibility:
All Genders
18-49 years
Phase:
NA
Brief Summary
Performance testing of pulse oximeters. The protocol involves brief stable arterial oxygen desaturation in healthy volunteers and sampling arterial blood when a stable level of hypoxia has been attain...
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 has both wrist circumferences between 14 and 22cm.
- 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.
- The subject has piercings that may cause air leaks during the test
- The subject has 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 a resting heartrate over 120, Systolic BP is over 150, diastolic BP is over 90 or room air SpO2 is less than 94%.
- The subject has carboxyhemoglobin over 3% as measured by Lab blood gas analysis.
- The subject has any other condition, which in the opinion of the investigators' would make them unsuitable to participate.
Key Trial Info
Start Date :
March 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 12 2020
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04380389
Start Date
March 11 2020
End Date
March 12 2020
Last Update
May 8 2020
Active Locations (1)
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1
Hypoxia Lab, UCSF
San Francisco, California, United States, 94133