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Completed

NCT Number: NCT05693961

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

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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Key information

Conditions

Healthy

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sky Labs

Gyeonggi-do, Pangyo, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CART-I plus

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

Primary outcomes

  1. Accuracy of SpO2

    Time frame: 1 day

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

Sponsors and collaborators

Lead sponsor

Sky Labs

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 23, 2023
Registry last updated
Jan 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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