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

January 12, 2023 updated by: Sky Labs

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sky Labs

Investigators

  • Principal Investigator: Byung-Moon Choi, MD, PhD, Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2021

Primary Completion (Actual)

June 19, 2021

Study Completion (Actual)

October 20, 2021

Study Registration Dates

First Submitted

January 12, 2023

First Submitted That Met QC Criteria

January 12, 2023

First Posted (Actual)

January 23, 2023

Study Record Updates

Last Update Posted (Actual)

January 23, 2023

Last Update Submitted That Met QC Criteria

January 12, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2021-0153

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on CART-I plus

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe