IntroductionAutomated continuous ambulatory monitoring may provide an alternative to intermittent manual vital signs monitoring. This has the potential to improve frequency of measurements, timely escalation of care and patient safety. However, a major barrier to the implementation of these wearable devices in the ward environment is their uncertain reliability, efficiency and data fidelity. The purpose of this study is to test performance of selected devices in a simulated clinical setting including during movement and low levels of peripheral oxygen saturation.Methods and analysisThis is a single centre, prospective, controlled, cross-sectional, diagnostic accuracy study to determine the specificity and sensitivity of currently available ambulatory vital signs monitoring equipment in the detection of hypoxia and the effect of movement on data acquisition. We will recruit up to 45 healthy volunteers who will attend a single study visit; starting with a movement phase and followed by the hypoxia exposure phase where we will gradually decrease saturation levels down to 80%. We will simultaneously test one chest patch, one wrist worn only and three wrist worn with finger probe devices against ‘clinical standard ‘and ‘gold standard’ references. We will measure peripheral oxygen saturations, pulse rate, heart rate and respiratory rate continuously and arterial blood gases intermittently throughout the study.Ethics and disseminationThis study has received ethical approval by the East of Scotland Research Ethics Service REC 2 (19/ES/0008). The results will be broadly distributed through conference presentations and peer-reviewed publications.Trial registration numberISRCTN61535692registered on 10/06/2019.
Background Commercially available wearable (ambulatory) pulse oximeters have been recommended as a method for managing patients at risk of physiological deterioration, such as active patients with COVID-19 disease receiving care in hospital isolation rooms; however, their reliability in usual hospital settings is not known. Objective We report the performance of wearable pulse oximeters in a simulated clinical setting when challenged by motion and low levels of arterial blood oxygen saturation (SaO2). Methods The performance of 1 wrist-worn (Wavelet) and 3 finger-worn (CheckMe O2+, AP-20, and WristOx2 3150) wearable, wireless transmission–mode pulse oximeters was evaluated. For this, 7 motion tasks were performed: at rest, sit-to-stand, tapping, rubbing, drinking, turning pages, and using a tablet. Hypoxia exposure followed, in which inspired gases were adjusted to achieve decreasing SaO2 levels at 100%, 95%, 90%, 87%, 85%, 83%, and 80%. Peripheral oxygen saturation (SpO2) estimates were compared with simultaneous SaO2 samples to calculate the root-mean-square error (RMSE). The area under the receiver operating characteristic curve was used to analyze the detection of hypoxemia (ie, SaO2<90%). Results SpO2 estimates matching 215 SaO2 samples in both study phases, from 33 participants, were analyzed. Tapping, rubbing, turning pages, and using a tablet degraded SpO2 estimation (RMSE>4% for at least 1 device). All finger-worn pulse oximeters detected hypoxemia, with an overall sensitivity of ≥0.87 and specificity of ≥0.80, comparable to that of the Philips MX450 pulse oximeter. Conclusions The SpO2 accuracy of wearable finger-worn pulse oximeters was within that required by the International Organization for Standardization guidelines. Performance was degraded by motion, but all pulse oximeters could detect hypoxemia. Our findings support the use of wearable, wireless transmission–mode pulse oximeters to detect the onset of clinical deterioration in hospital settings. Trial Registration ISRCTN Registry 61535692; http://www.isrctn.com/ISRCTN61535692 International Registered Report Identifier (IRRID) RR2-10.1136/bmjopen-2019-034404
BACKGROUND Commercially available wearable (ambulatory) pulse oximeters have been recommended as a method for managing patients at risk of physiological deterioration, such as active patients with COVID-19 disease receiving care in hospital isolation rooms, however, their reliability is unclear to use in the hospital setting. OBJECTIVE We report the performance of wearable pulse oximeters in a simulated clinical setting when challenged by motion and low levels of arterial blood oxygen (SaO2). METHODS The performance of one wrist-worn (Wavelet) and three finger-worn (CheckMeTM O2+, AP-20 and WristOx2® 3150) wearable, wireless transmission-mode, pulse oximeters was evaluated. Seven motion tasks were performed: At rest, Sit-to-Stand, Tapping, Rubbing, Drinking, Turning Pages, and Using a Tablet. Hypoxia exposure followed, in which inspired gases were adjusted to achieve decreasing SaO2 levels at 100%, 95%, 90%, 87%, 85%, 83% and 80%. Peripheral oxygen saturation (SpO2) estimates were compared with simultaneous SaO2 samples to calculate the root mean squared error (RMSE). Area under the receiver-operating characteristic curve was used to analyse the detection of hypoxaemia, SaO2 < 90%. RESULTS SpO2 estimates matching 215 SaO2 samples in both study phases, from 33 participants, were analysed. Tapping, rubbing, turning pages and using a tablet degraded SpO2 estimation (RMSE > 4% for a least one device). All finger-worn pulse oximeters detected hypoxaemia, with an overall sensitivity ≥ 0.87 and specificity ≥ 0.80, comparable to that of the Philips MX450. CONCLUSIONS The SpO2 accuracy of wearable finger-worn pulse oximeters was within that required by the International Organization for Standardization guidelines. Performance was degraded by motion, but all were capable of detecting hypoxaemia. Our findings support the use of wearable, wireless transmission-mode, pulse oximeters to detect the onset of clinical deterioration in hospital settings. CLINICALTRIAL ISRCTN61535692; http://www.isrctn.com/ISRCTN61535692 INTERNATIONAL REGISTERED REPORT RR2-10.1136/bmjopen-2019-034404
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