Arik Eisenkraft, Nir Goldstein, Arik Ben Ishay, Meir Fons, Michael Tabi, Anna Danielle Sherman, Roei Merin, Dean Nachman
{"title":"可穿戴呼吸频率设备的临床验证：一份简短的报告。","authors":"Arik Eisenkraft, Nir Goldstein, Arik Ben Ishay, Meir Fons, Michael Tabi, Anna Danielle Sherman, Roei Merin, Dean Nachman","doi":"10.1177/14799731231198865","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Respiratory rate (RR) is used for the diagnosis and management of medical conditions and can predict clinical changes. Heavy workload, understaffing, and errors related to poor recording make it underutilized. Wearable devices may facilitate its use.</p><p><strong>Methods: </strong>RR measurements using a wearable photoplethysmography-based monitor were compared with medical grade devices in complementary clinical scenarios: Study one included a comparison to a capnograph in 35 healthy volunteers; Study two included a comparison to a ventilator monitor in 18 ventilated patients; and Study three included a comparison to capnograph in 92 COVID-19 patients with active pulmonary disease. Pearson's correlations and Bland-Altman analysis were used to assess the accuracy and agreement between the measurement techniques, including stratification for Body Mass Index (BMI) and skin tone. Statistical significance was set at <i>p</i> ≤ 0.05.</p><p><strong>Results: </strong>High correlation was found in all studies (r = 0.991, 0.884, and 0.888, respectively, <i>p</i> < 0.001 for all). 95% LOA of ±2.3, 1.7-(-1.6), and ±3.9 with a bias of < 0.1 breaths per minute was found in Bland-Altman analysis in studies 1,2, and 3, respectively. In all, high accordance was found in all sub-groups.</p><p><strong>Conclusions: </strong>RR measurements using the wearable monitor were highly-correlated with medical-grade devices in various clinical settings.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov, https://clinicaltrials.gov/ct2/show/NCT03603860.</p>","PeriodicalId":10217,"journal":{"name":"Chronic Respiratory Disease","volume":"20 ","pages":"14799731231198865"},"PeriodicalIF":3.5000,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/7b/d9/10.1177_14799731231198865.PMC10461800.pdf","citationCount":"0","resultStr":"{\"title\":\"Clinical validation of a wearable respiratory rate device: A brief report.\",\"authors\":\"Arik Eisenkraft, Nir Goldstein, Arik Ben Ishay, Meir Fons, Michael Tabi, Anna Danielle Sherman, Roei Merin, Dean Nachman\",\"doi\":\"10.1177/14799731231198865\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Respiratory rate (RR) is used for the diagnosis and management of medical conditions and can predict clinical changes. Heavy workload, understaffing, and errors related to poor recording make it underutilized. Wearable devices may facilitate its use.</p><p><strong>Methods: </strong>RR measurements using a wearable photoplethysmography-based monitor were compared with medical grade devices in complementary clinical scenarios: Study one included a comparison to a capnograph in 35 healthy volunteers; Study two included a comparison to a ventilator monitor in 18 ventilated patients; and Study three included a comparison to capnograph in 92 COVID-19 patients with active pulmonary disease. Pearson's correlations and Bland-Altman analysis were used to assess the accuracy and agreement between the measurement techniques, including stratification for Body Mass Index (BMI) and skin tone. Statistical significance was set at <i>p</i> ≤ 0.05.</p><p><strong>Results: </strong>High correlation was found in all studies (r = 0.991, 0.884, and 0.888, respectively, <i>p</i> < 0.001 for all). 95% LOA of ±2.3, 1.7-(-1.6), and ±3.9 with a bias of < 0.1 breaths per minute was found in Bland-Altman analysis in studies 1,2, and 3, respectively. 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Clinical validation of a wearable respiratory rate device: A brief report.
Background: Respiratory rate (RR) is used for the diagnosis and management of medical conditions and can predict clinical changes. Heavy workload, understaffing, and errors related to poor recording make it underutilized. Wearable devices may facilitate its use.
Methods: RR measurements using a wearable photoplethysmography-based monitor were compared with medical grade devices in complementary clinical scenarios: Study one included a comparison to a capnograph in 35 healthy volunteers; Study two included a comparison to a ventilator monitor in 18 ventilated patients; and Study three included a comparison to capnograph in 92 COVID-19 patients with active pulmonary disease. Pearson's correlations and Bland-Altman analysis were used to assess the accuracy and agreement between the measurement techniques, including stratification for Body Mass Index (BMI) and skin tone. Statistical significance was set at p ≤ 0.05.
Results: High correlation was found in all studies (r = 0.991, 0.884, and 0.888, respectively, p < 0.001 for all). 95% LOA of ±2.3, 1.7-(-1.6), and ±3.9 with a bias of < 0.1 breaths per minute was found in Bland-Altman analysis in studies 1,2, and 3, respectively. In all, high accordance was found in all sub-groups.
Conclusions: RR measurements using the wearable monitor were highly-correlated with medical-grade devices in various clinical settings.
期刊介绍：
Chronic Respiratory Disease is a peer-reviewed, open access, scholarly journal, created in response to the rising incidence of chronic respiratory diseases worldwide. It publishes high quality research papers and original articles that have immediate relevance to clinical practice and its multi-disciplinary perspective reflects the nature of modern treatment. The journal provides a high quality, multi-disciplinary focus for the publication of original papers, reviews and commentary in the broad area of chronic respiratory disease, particularly its treatment and management.
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