Clinical evaluation of a wearable sensor for mobile monitoring of respiratory rate on hospital wards

Järvelä, Kristiina; Takala, Panu; Michard, Frédèric; Vikatmaa, Leena

doi:10.1007/s10877-021-00753-6

Cited by 10 publications

(9 citation statements)

References 24 publications

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“…Twenty‐five studies of wearable devices provided sufficient information to determine respiratory rate range. Of these, 15 contained respiratory rates < 8 breaths.min ‐1 [13, 19, 22, 23, 26, 28, 35, 54–61] and 15 contained respiratory rates > 30 breaths.min ‐1 [13, 18, 19, 21–27, 31, 35, 56, 60, 61]. Twelve studies of contactless devices provided respiratory rate range.…”

Section: Resultsmentioning

confidence: 99%

“…France) [34]. Of these, all except for three [31,34,35] had easily verifiable regulatory approval from a national regulatory agency. Because the Vitalconnect Healthpatch is the same device as the Philips Wearable Sensor but with updated respiratory rate algorithms, for the purposes of heart rate they were taken to be the same device, and for the purposes of respiratory rate they were interpreted separately.…”

Section: Resultsmentioning

confidence: 99%

“…A Clarke error grid, used to highlight how often incorrect values might lead to incorrect treatment decisions [77], was employed in five [13,19,23,35,49] wearable and two [60,62] studies of contactless devices. Separate assessment of device performance at different ranges of vital signs was performed in four [33,38,50,73] and two [63,76] cases.…”

Section: Resultsmentioning

confidence: 99%

“…These were: Vitalconnect™ Healthpatch/Philips Wearable Biosensor (Vitalconnect™, San Jose, CA, USA and Koninklijke Philips N.V, Amsterdam, The Netherlands) [13, 17–23]; SensiumVitals (The Surgical Company, Oxford, UK) [13, 24–26]; Respirasense (PMD, Cork, Ireland) [27]; Philips Healthdot [28] (Koninklijke Philips N.V); CoVA (Tosense, San Diego, CA, USA) [29]; Biostamp (MC10, Lexington, KY, USA) [30]; Respiheart (Respiheart, Linköping, Sweden) [31]; Zephyr (Medtronic, Minneapolis, MN, USA) [32, 33]; and Multisense (RDS, Strasbourg, France) [34]. Of these, all except for three [31, 34, 35] had easily verifiable regulatory approval from a national regulatory agency. Because the Vitalconnect Healthpatch is the same device as the Philips Wearable Sensor but with updated respiratory rate algorithms, for the purposes of heart rate they were taken to be the same device, and for the purposes of respiratory rate they were interpreted separately.…”

Section: Resultsmentioning

confidence: 99%

“…The clinical significance of this is unclear, as it is unknown whether the inaccurate reading would have led to a change in patient management. A Clarke error grid was used to identify whether management would change with inaccurate values in only five wearable [13,19,23,35,49] and two contactless [60,62] studies. This proved very useful in determining how novel devices might change clinical decision making.…”

Section: Discussionmentioning

confidence: 99%

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Novel wearable and contactless heart rate, respiratory rate, and oxygen saturation monitoring devices: a systematic review and meta‐analysis

et al. 2022

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We performed a systematic review and meta-analysis to identify, classify and evaluate the body of evidence on novel wearable and contactless devices that measure heart rate, respiratory rate and oxygen saturations in the clinical setting. We included any studies of hospital inpatients, including sleep study clinics. Eighty-four studies were included in the final review. There were 56 studies of wearable devices and 29 of contactless devices. One study assessed both types of device. A high risk of patient selection and rater bias was present in proportionally more studies assessing contactless devices compared with studies assessing wearable devices (p = 0.023 and p < 0.0001, respectively). There was high but equivalent likelihood of blinding bias between the two types of studies (p = 0.076). Wearable device studies were commercially available devices validated in acute clinical settings by clinical staff and had more real-time data analysis (p = 0.04). Contactless devices were more experimental, and data were analysed post-hoc. Pooled estimates of mean (95%CI) heart rate and respiratory rate bias in wearable devices were 1.25 (À0.31-2.82) beats.min -1 (pooled 95% limits of agreement À9.36-10.08) and 0.68 (0.05-1.32) breaths.min -1 (pooled 95% limits of agreement À5.65-6.85). The pooled estimate for mean (95%CI) heart rate and respiratory rate bias in contactless devices was 2.18 (3.31-7.66) beats.min -1 (pooled limits of agreement À6.71-10.88) and 0.30 (À0.26-0.87) breaths.min -1 (pooled 95% limits of agreement À3. 94-4.29). Only two studies of wearable devices measured S p O 2 ; these reported mean measurement biases of 3.54% (limits of agreement À5.65-11.45%) and 2.9% (À7.4-1.7%). Heterogeneity was observed across studies, but absent when devices were grouped by measurement modality and reference standard. We conclude that, while studies of wearable devices were of slightly better quality than contactless devices, in general all studies of novel devices were of low quality, with small (< 100) patient datasets, typically not blinded and often using inappropriate statistical techniques. Both types of devices were statistically equivalent in accuracy and precision, but wearable devices demonstrated less measurement bias and more precision at extreme vital signs. The statistical variability in precision and accuracy between studies is partially explained by differences in reference standards.

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Section: Resultsmentioning

confidence: 99%