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

Sky Labs

Status: Completed

Conditions: Healthy

Treatments: Device: CART-I plus

Study type: Interventional

Funder types: Industry

Identifiers

NCT05693961

2021-0153

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

CART-I plus

Experimental group

Description:

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.

Treatment:

Device: CART-I plus