Controlled Desaturation Study for TipTraQ SpO2 Performance Validation
Completed
Conditions studied: Hypoxia
In brief
The objective is to validate the performance of SpO2 measurement of the TipTraQ by comparing it with measurement from an artery blood sample of a healthy volunteer in a controlled desaturation study. The overall framework of the validation process followed Annex EE.2 of ISO 80601-2-61:2019.
Key facts
- Study ID
- NCT06634693
- Run by
- PranaQ Pte. Ltd.
- People needed
- 12
- Starts
- 2023-10-10
- Expected to finish
- 2023-10-11
- Last updated by the study team
- 2024-10-10
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Participant must have the ability to understand and provide written informed consent
- A participant is an adult 18-50 years of age
- Participant must be willing and able to comply with study procedures and duration
- Participant is a non-smoker or who has not smoked within 2 days before the study.
You may not qualify if…
- Participant is considered as being morbidly obese (defined as BMI >39.5)
- Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears, forehead/skull, or other sensor sites would limit the ability to test sites needed for the study. Tattoos in the optical path would limit the ability to test sites needed for the study.
- Participants with known respiratory conditions
- Uncontrolled/severe asthma
- pneumonia/bronchitis
- shortness of breath / respiratory distress, unresolved respiratory or lung surgery, emphysema, COPD, lung disease
- Recent COVID (last 2 months)
- Participants with self-reported heart or cardiovascular conditions
- chest pain (angina)
- heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia
- previous heart attack
- blocked artery
- congestive heart failure (CHF)
Where it is running
- UCSF Medical Center at Parnassus — San Francisco, California, United States
Full record on ClinicalTrials.gov
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