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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05693961
• Other study ID #: 2021-0153
• Status: Completed
• Phase: N/A
• Start date: June 12, 2021
• Est. completion date: October 20, 2021

Study information

• Verified date: January 2023
• Source: Sky Labs
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: October 20, 2021
• Est. primary completion date: June 19, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Sky Labs	Gyeonggi-do	Pangyo

Sponsors (1)

Lead Sponsor	Collaborator
Sky Labs

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of SpO2	Mean bias, standard deviation, standard error, maximum/minimum bias, precision are calcuated	1 day