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

NCT05693961 | Completed

• 1 other identifier: 2021-0153
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Oxygen Saturation

Outcome Measures

Primary Outcomes (1)

• Accuracy of SpO2

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

  1 day

Study Arms (1)

CART-I plus

EXPERIMENTAL

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

Interventions

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

CART-I plus

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sky Labs: lead

Study Sites (1)

Sky Labs

Gyeonggi-do, Pangyo, South Korea

Location

Related Publications (4)

• Luks AM, Swenson ER. Pulse Oximetry for Monitoring Patients with COVID-19 at Home. Potential Pitfalls and Practical Guidance. Ann Am Thorac Soc. 2020 Sep;17(9):1040-1046. doi: 10.1513/AnnalsATS.202005-418FR.

  PMID: 32521167 BACKGROUND

• Agarwala P, Salzman SH. Six-Minute Walk Test: Clinical Role, Technique, Coding, and Reimbursement. Chest. 2020 Mar;157(3):603-611. doi: 10.1016/j.chest.2019.10.014. Epub 2019 Nov 2.

  PMID: 31689414 BACKGROUND

• Andres-Blanco AM, Alvarez D, Crespo A, Arroyo CA, Cerezo-Hernandez A, Gutierrez-Tobal GC, Hornero R, Del Campo F. Assessment of automated analysis of portable oximetry as a screening test for moderate-to-severe sleep apnea in patients with chronic obstructive pulmonary disease. PLoS One. 2017 Nov 27;12(11):e0188094. doi: 10.1371/journal.pone.0188094. eCollection 2017.

  PMID: 29176802 BACKGROUND

• Shiao SY, Ou CN. Validation of oxygen saturation monitoring in neonates. Am J Crit Care. 2007 Mar;16(2):168-78.

  PMID: 17322018 BACKGROUND

Study Officials

• Byung-Moon Choi, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: January 23, 2023
• Study Start: June 12, 2021
• Primary Completion: June 19, 2021
• Study Completion: October 20, 2021
• Last Updated: January 23, 2023

Record last verified: 2023-01

Locations

KR (1)