Wrist-Sensor Pulse Oximeter Enables Prolonged Patient Monitoring in Chronic Lung Diseases

Guber, Alexander; Shochet, Gali Epstein; Kohn, Sarah; Shitrit, David

doi:10.1007/s10916-019-1317-2

Cited by 29 publications

(14 citation statements)

References 16 publications

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“…Other recent studies have also reported positive results on the accuracy of wrist SpO 2 measurements by commercial devices, but most of them did not focus on hypoxia. 39 – 42 …”

Section: Introductionmentioning

confidence: 99%

Commercial smartwatch with pulse oximeter detects short-time hypoxemia as well as standard medical-grade device: Validation study

et al. 2022

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Objective We investigated how a commercially available smartwatch that measures peripheral blood oxygen saturation (SpO2) can detect hypoxemia compared to a medical-grade pulse oximeter. Methods We recruited 24 healthy participants. Each participant wore a smartwatch (Apple Watch Series 6) on the left wrist and a pulse oximeter sensor (Masimo Radical-7) on the left middle finger. The participants breathed via a breathing circuit with a three-way non-rebreathing valve in three phases. First, in the 2-minute initial stabilization phase, the participants inhaled the ambient air. Then in the 5-minute desaturation phase, the participants breathed the oxygen-reduced gas mixture (12% O2), which temporarily reduced their blood oxygen saturation. In the final stabilization phase, the participants inhaled the ambient air again until SpO2 returned to normal values. Measurements of SpO2 were taken from the smartwatch and the pulse oximeter simultaneously in 30-s intervals. Results There were 642 individual pairs of SpO2 measurements. The bias in SpO2 between the smartwatch and the oximeter was 0.0% for all the data points. The bias for SpO2 less than 90% was 1.2%. The differences in individual measurements between the smartwatch and oximeter within 6% SpO2 can be expected for SpO2 readings 90%–100% and up to 8% for SpO2 readings less than 90%. Conclusions Apple Watch Series 6 can reliably detect states of reduced blood oxygen saturation with SpO2 below 90% when compared to a medical-grade pulse oximeter. The technology used in this smartwatch is sufficiently advanced for the indicative measurement of SpO2 outside the clinic. Trial Registration ClinicalTrials.gov NCT04780724

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“…Other recent studies have also reported positive results on the accuracy of wrist SpO 2 measurements by commercial devices, but most of them did not focus on hypoxia. 39 – 42 …”

Section: Introductionmentioning

confidence: 99%

Commercial smartwatch with pulse oximeter detects short-time hypoxemia as well as standard medical-grade device: Validation study

et al. 2022

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“…Finally, the objective of this work was the implementation of ISO/IEEE 11073 PHD SpO2 and ECG device specializations over Bluetooth HDP following the Health Care Profile. A qualitative and quantitative evaluation could be interesting in the methodology for our future work following recommendations from other authors [ 30 , 31 , 32 ].…”

Section: Discussionmentioning

confidence: 99%

Implementation of ISO/IEEE 11073 PHD SpO2 and ECG Device Specializations over Bluetooth HDP following Health Care Profile for Smart Living

Cristobal-Huerta

Torrado‐Carvajal

Rodriguez‐Sanchez

et al. 2022

Sensors

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Current m-Health scenarios in the smart living era, as the interpretation of the smart city at each person’s level, present several challenges associated with interoperability between different clinical devices and applications. The Continua Health Alliance establishes design guidelines to standardize application communication to guarantee interoperability among medical devices. In this paper, we describe the implementation of two IEEE agents for oxygen saturation level (SpO2) measurements and electrocardiogram (ECG) data acquisition, respectively, and a smartphone IEEE manager for validation. We developed both IEEE agents over the Bluetooth Health Device Profile following the Continua guidelines and they are part of a telemonitoring system. This system was evaluated in a sample composed of 10 volunteers (mean age 29.8 ± 7.1 y/o; 5 females) under supervision of an expert cardiologist. The evaluation consisted of measuring the SpO2 and ECG signal sitting and at rest, before and after exercising for 15 min. Physiological measurements were assessed and compared against commercial devices, and our expert physician did not find any relevant differences in the ECG signal. Additionally, the system was assessed when acquiring and processing different heart rate data to prove that warnings were generated when the heart rate was under/above the thresholds for bradycardia and tachycardia, respectively.

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“…FDA guidance and the ISO 80601-2-61:2017 standard require RMSEs below 3.5% and 4% for reflectance pulse oximeter approval, respectively [27,28]. These criteria were recently fulfilled by a wrist-sensor pulse oximeter, the Oxitone 1000, in a study in which its precision and accuracy were tested and an RMSE of 3% was reported [29]. Here, out of the conclusive measurements collected from the 14 participants, we have shown that the Withings ScanWatch exhibited acceptable RMSE levels for SpO 2 that were below the thresholds defined by these authorities.…”

Section: Discussionmentioning

confidence: 99%

Validation of the Withings ScanWatch as a Wrist-Worn Reflective Pulse Oximeter: Prospective Interventional Clinical Study (Preprint)

Kirszenblat¹,

Edouard²

2021

Preprint

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BACKGROUND A decrease in the pulse oxygen saturation (SpO2) level is an indicator of hypoxemia that may occur in various respiratory diseases such as chronic obstructive pulmonary disease (COPD), sleep apnea syndrome (SAS) and the coronavirus disease (COVID-19). There is currently no mass-market wrist-worn SpO2 monitor meeting 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 Withings ScanWatch’s reflective pulse oximeter function to measure SpO2 levels at different stages of hypoxia. The secondary objective is to confirm the safety of this device when used as intended. METHODS To achieve these objectives, we included 14 healthy participants aged 23 to 39, and we induced several stable plateaus of arterial oxygen saturation (SaO2) ranging from 100% to 70% to mimic non-hypoxic conditions and then mild, moderate, and severe hypoxic conditions. We measured the SpO2 level with a Withings ScanWatch on each participant’s wrist and the SaO2 from blood samples with a co-oximeter, the ABL90 hemoximeter. RESULTS After removal of the inconclusive measurements, we had 275 and 244 conclusive measurements with the two ScanWatches on the participants’ right and left wrists, evenly distributed among the 3 predetermined SpO2 groups: SpO2 ≤ 80%, 80% < SpO2 ≤ 90% and 90% < SpO2. We found a strong association and a high level of agreement between the measurements collected from the devices, with a high Pearson correlation coefficient (PCC) of r = 0.944 and r = 0.954 on correlation plots, a low PCC of r = 0.083 (p = 0.166) and r = 0.23 (p = 0.0013) on Bland-Altman plots, and a Root Mean Square Error (RMSE) of 2.97% and 3.00% from the participants’ right and left hands, respectively. CONCLUSIONS In conclusion, the Withings ScanWatches is able to measure SpO2 levels with an adequate accuracy at a clinical grade. No undesirable effects or adverse events were reported during the study. CLINICALTRIAL This clinical study, ”Accuracy of ScanWatch Pulse Oximeter With Profound Hypoxia” (Clinical Trials Registration Number: NCT04380389), was conducted in compliance with Good Clinical Practices (ISO 14155:2011, ICH guidelines) and the declaration of Helsinki after approval from the Institutional Review Board (IRB), Laurel Heights Panel, on March 9, 2020. (NIRB: 10-00437, N Reference: 272720 I). The selected eligible participants were informed and gave their signed consent prior to enrollment.

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Wrist-Sensor Pulse Oximeter Enables Prolonged Patient Monitoring in Chronic Lung Diseases

Cited by 29 publications

References 16 publications

Commercial smartwatch with pulse oximeter detects short-time hypoxemia as well as standard medical-grade device: Validation study

Commercial smartwatch with pulse oximeter detects short-time hypoxemia as well as standard medical-grade device: Validation study

Implementation of ISO/IEEE 11073 PHD SpO2 and ECG Device Specializations over Bluetooth HDP following Health Care Profile for Smart Living

Validation of the Withings ScanWatch as a Wrist-Worn Reflective Pulse Oximeter: Prospective Interventional Clinical Study (Preprint)

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