Background A decrease in the level of pulse oxygen saturation as measured by pulse oximetry (SpO 2 ) is an indicator of hypoxemia that may occur in various respiratory diseases, such as chronic obstructive pulmonary disease (COPD), sleep apnea syndrome, and COVID-19. Currently, no mass-market wrist-worn SpO 2 monitor meets the medical standards for pulse oximeters. Objective The main objective of this monocentric and prospective clinical study with single-blind analysis was to test and validate the accuracy of the reflective pulse oximeter function of the Withings ScanWatch to measure SpO 2 levels at different stages of hypoxia. The secondary objective was to confirm the safety of this device when used as intended. Methods To achieve these objectives, we included 14 healthy participants aged 23-39 years in the study, and we induced several stable plateaus of arterial oxygen saturation (SaO 2 ) ranging from 100%-70% to mimic nonhypoxic conditions and then mild, moderate, and severe hypoxic conditions. We measured the SpO 2 level with a Withings ScanWatch on each participant’s wrist and the SaO 2 from blood samples with a co-oximeter, the ABL90 hemoximeter (Radiometer Medical ApS). Results After removal of the inconclusive measurements, we obtained 275 and 244 conclusive measurements with the two ScanWatches on the participants’ right and left wrists, respectively, evenly distributed among the 3 predetermined SpO 2 groups: SpO 2 ≤80%, 80%
【저자키워드】 COVID-19, Safety, SpO2, oxygen, COPD, Neural network, validation, Accuracy, Respiratory disease, respiratory, wearable, connected watch, pulse oxygen saturation, reflective pulse oximeter, sleep apnea syndrome, Withings ScanWatch, oximeter, 【초록키워드】 hypoxia, sleep apnea, pulse oximetry, oxygen, respiratory diseases, COPD, adverse events, Registration, oxygen saturation, Hypoxemia, adverse event, Mild, correlation, moderate, pulmonary disease, association, clinical study, Analysis, chronic obstructive pulmonary disease, sleep apnea syndrome, oximeter, obstructive pulmonary disease, arterial oxygen saturation, Pulse oximeter, Indicator, 95% CI, hands, Blood samples, mass, blood sample, Stage, removal, single-blind, participant, hypoxic conditions, biases, pulse, MONITOR, Pearson correlation coefficient, Effect, Inconclusive, objective, decrease, Bland, Result, collected, healthy, reported, condition, occur, chronic obstructive, meet, Radiometer, 【제목키워드】 clinical, Prospective,
Validation of the Withings ScanWatch as a Wrist-Worn Reflective Pulse Oximeter: Prospective Interventional Clinical Study
Withings ScanWatch를 손목에 착용하는 반사형 맥박 산소 농도계로 검증: 전향적 중재 임상 연구
[키워드] 95% CI
Accuracy
adverse event
adverse events
Analysis
arterial oxygen saturation
association
biases
Bland
blood sample
Blood samples
chronic obstructive
chronic obstructive pulmonary disease
clinical
clinical study
collected
condition
connected watch
COPD
correlation
COVID-19
decrease
Effect
hands
healthy
Hypoxemia
hypoxia
hypoxic conditions
Inconclusive
Indicator
mass
meet
Mild
moderate
MONITOR
Neural network
objective
obstructive pulmonary disease
occur
oximeter
oxygen
oxygen saturation
participant
Pearson correlation coefficient
Prospective
pulmonary disease
pulse
Pulse oximeter
pulse oximetry
pulse oxygen saturation
Radiometer
reflective pulse oximeter
Registration
removal
reported
respiratory
Respiratory disease
respiratory diseases
Result
Safety
single-blind
sleep apnea
sleep apnea syndrome
SpO2
Stage
validation
wearable
Withings ScanWatch
[Category] MERS, 임상, 진단,
PMC URL [DOI] 10.2196/27503
[Article Type] Clinical Trial
[Source] PMC
All Keywords
배경 맥박산소측정법(SpO 2 )으로 측정한 맥박산소포화도의 감소는 만성폐쇄성폐질환(COPD), 수면무호흡증후군, 코로나19 등 다양한 호흡기 질환에서 발생할 수 있는 저산소혈증의 지표다. . 현재 대중 시장에서 손목에 착용하는 SpO 2 모니터는 맥박 산소 측정기의 의료 표준을 충족하지 않습니다. 목적 단일 맹검 분석을 사용한 이 단일 중심 및 전향적 임상 연구의 주요 목적은 저산소증의 여러 단계에서 SpO 2 수준을 측정하기 위해 Withings ScanWatch의 반사형 맥박 산소 측정기 기능의 정확성을 테스트하고 검증하는 것이었습니다. 두 번째 목적은 의도한 대로 사용할 때 이 장치의 안전성을 확인하는 것이었습니다. 방법 이러한 목표를 달성하기 위해 우리는 연구에 23-39세의 건강한 참가자 14명을 포함시켰고 100%-70% 범위의 동맥 산소 포화도(SaO 2 )의 몇 가지 안정적인 고원을 유도하여 저산소 상태가 아닌 조건을 모방한 다음 경증, 중등도 , 심한 저산소 상태. 우리는 각 참가자의 손목에 Withings ScanWatch를 사용하여 SpO 2 수준을 측정하고 공동 산소 측정기 ABL90 혈색소 측정기(Radiometer Medical ApS)를 사용하여 혈액 샘플에서 SaO 2 수준을 측정했습니다. 결과 결정적이지 않은 측정값을 제거한 후 참가자의 오른쪽 및 왼쪽 손목에 각각 두 개의 ScanWatch를 사용하여 275개 및 244개의 결정적인 측정값을 얻었습니다. SpO 2 ≤80%, 80%