An Invasive Controlled Desaturation Study to Determine the Accuracy of the CART-I Pulse Oximeter (Sky Labs Inc., Korea) in Healthy Adult Volunteers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Sky Labs
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- Accuracy of SpO2
Study Overview
Brief Summary
A pulse oximeter is used for continuous monitoring of peripheral oxygen saturation (SpO2) and plays an important role in the early detection of hypoxia, guiding the titration of supplemental oxygen, and reducing the need for blood gas analysis. Therefore, the SpO2 accuracy of a pulse oximeter should be validated for patient safety. The objective of this study is to evaluate whether the CART-I pulse oximeter with a ring-type wearable PPG sensor (Sky Labs Inc., Seoul, Korea) provides clinically reliable SpO2 readings over the range of 70-100% SaO2, during steady-state, non-motion conditions.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy adults aged 20-50 years2
- •COHb < 3 %
- •MetHb < 2 %
- •ctHb > 10 g/dl
- •Non-smoker
- •An individual deemed fit by the investigators to be included in the clinical trial
Exclusion Criteria
- •History of respiratory disease
- •History of cardiovascular disease
- •History of fainting
- •History of diabetes
- •Obesity (defined as BMI > 30 kg/m2)
- •Allen's test positive (poor collateral blood supply of hand)
- •An individual who is judged to be difficult for the collection of normal PPG signals because CART-I is loose when being worn on fingers other than the thumb and little finger
Arms & Interventions
CART-I plus
CART-I pulse oximeter with a ring-type wearable PPG sensor was placed on each volunteer to evaluate the SpO2 accuracy during steady-state, non-motion conditions.
Intervention: CART-I plus (Device)
Outcomes
Primary Outcomes
Accuracy of SpO2
Time Frame: 1 day
Mean bias, standard deviation, standard error, maximum/minimum bias, precision are calcuated
Secondary Outcomes
No secondary outcomes reported