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

An Invasive Controlled Desaturation Study to Determine the Accuracy of the CART-I Pulse Oximeter (Sky Labs Inc., Korea) in Healthy Adult Volunteers

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05693961

Enrollment

Registered

2023-01-23

Start date

2021-06-12

Completion date

2021-10-20

Last updated

2023-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Oxygen Saturation

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.

Interventions

DEVICECART-I plus

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 50 Years

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 * 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

Design outcomes

Primary

Measure	Time frame	Description
Accuracy of SpO2	1 day	Mean bias, standard deviation, standard error, maximum/minimum bias, precision are calcuated

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026