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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of SpO2 | Mean bias, standard deviation, standard error, maximum/minimum bias, precision are calcuated | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Byung-Moon Choi, MD, PhD | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sky Labs | Gyeonggi-do | Pangyo | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32521167 | Background | 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. | |
| 31689414 | 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. |
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| 29176802 | 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. |
| 17322018 | Background | Shiao SY, Ou CN. Validation of oxygen saturation monitoring in neonates. Am J Crit Care. 2007 Mar;16(2):168-78. |