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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-12

Study Completion Date

2021-10-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

CART-I plus

Intervention Type DEVICE

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

Interventions

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CART-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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes