Status:
COMPLETED
The Accuracy of the Dormotech VLAB During Stable Hypoxia Plateaus
Lead Sponsor:
Dormotech Medical
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Brief Summary
The purpose of the study is to determine the accuracy of the Dormotech VLAB (SpO2) Sensor in accordance with the FDA Guidance on Pulse Oximeters - Premarket Notification Submissions \[510(k)s\], in ra...
Detailed Description
The purpose of the study is to determine the accuracy of the Dormotech VLAB (SpO2) Sensor in accordance with the FDA Guidance on Pulse Oximeters - Premarket Notification Submissions \[510(k)s\], in th...
Eligibility Criteria
Inclusion
- Subject is male or Subject is male or female, aged 18 and \< 50.
- Subject is in good health with no evidence of any medical problems.
- Subject is fluent in both written and spoken English.
- Subject has provided informed consent and is willing to comply with the study procedure
Exclusion
- Subject is obese (BMI \>35).
- Subject has 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.
- Subject uses any anticoagulative medication (blood thinner).
- Subject has 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.
- Subject has any other serious systemic illness.
- Subject is a current smoker.
- Subject with any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators would interfere with the sensors working correctly.
- Subject has a history of fainting or vasovagal response.
- Subject has a history of sensitivity to local anesthesia
- Subject has a diagnosis of Raynaud's disease
- Subject has claustrophobia
- Subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).
- Subject is pregnant, lactating or trying to get pregnant.
- Subject is unable or unwilling to provide informed consent or is unable or unwilling to comply with study procedures.
- 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 15 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 30 2024
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06516809
Start Date
May 15 2024
End Date
May 30 2024
Last Update
July 24 2024
Active Locations (1)
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1
Vital Signs Research Group
San Francisco, California, United States, 94107