An Invasive Controlled Desaturation Study to Determine the Accuracy of the CART-I Pulse Oximeter

Sky Labs13 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

CART-I plusDEVICE

CART-I noninvasively measures the oxygen saturation of blood in a local area by screening the bloodstream through the user's finger using PPG signals

Eligibility

Sex: ALLMin age: 20 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 * Smoker * Pregnant * 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

Locations (1)

Sky Labs

Gyeonggi-do, Pangyo, South Korea

Outcomes

Primary Outcomes

Accuracy of SpO2

Mean bias, standard deviation, standard error, maximum/minimum bias, precision are calcuated

Time frame: 1 day

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.