Dataset Information

The Use of Wearable Pulse Oximeters in the Prompt Detection of Hypoxemia and During Movement: Diagnostic Accuracy Study.

ABSTRACT:

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.

SUBMITTER: Santos M

PROVIDER: S-EPMC8889481 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

The Use of Wearable Pulse Oximeters in the Prompt Detection of Hypoxemia and During Movement: Diagnostic Accuracy Study.

Santos Mauro M Vollam Sarah S Pimentel Marco Af MA Areia Carlos C Young Louise L Roman Cristian C Ede Jody J Piper Philippa P King Elizabeth E Harford Mirae M Shah Akshay A Gustafson Owen O Tarassenko Lionel L Watkinson Peter P

Journal of medical Internet research 20220215 2

<h4>Background</h4>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.<h4>Objective</h4>We report the performance of wearable pulse oximeters in a simulated clinical setting when challenged by motion and low levels of arterial blood oxyg ...[more]

PMID: 35166690

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Project description:BackgroundPulse oximeters are used to measure [Formula: see text] and pulse rate. These devices are either standalone machines or integrated into physiologic monitoring systems. Some smartphones now have pulse oximetry capabilities. Because it is possible that some patients might utilize this technology, we sought to assess the accuracy and usability of smartphone pulse oximeters.MethodsThis was a prospective, observational study that involved noninvasive measurements of [Formula: see text] and heart rate with 3 devices: Masimo Radical-7, Kenek Edge with the Apple iPhone 6S, and the Samsung S8 smartphone. Ambulatory adult patients visiting our institution's pulmonary function lab for a 6-min walk test were eligible to participate in the study. Pretest and posttest results for each subject were obtained simultaneously using all 3 devices. All results were analyzed with the Spearman rho correlation test, and Bland-Altman plots were used to assess the agreement of measures between the devices.ResultsForty-seven subjects were enrolled in the study, with pulmonary hypertension (30%) and COPD (23%) being the 2 major diagnoses. The mean ± SD difference between the Masimo and Apple devices for pretest [Formula: see text] was 2.3 ± 2.4%, and the difference for posttest [Formula: see text] was 2.1 ± 3.9%. The mean difference between the Masimo and Samsung devices for pretest [Formula: see text] was 3.2 ± 2.8%, and the difference for posttest [Formula: see text] was 2.4 ± 3.5%. The number of subjects who were unable to obtain [Formula: see text] was higher with the Samsung device than with the Apple device in both pretest (14 of 47 vs 3 of 47) and posttest (17 of 47 vs 5 of 47). In contrast, the Masimo device was able to measure [Formula: see text] in all subjects.ConclusionsSmartphone pulse oximeters were unreliable compared to a hospital pulse oximeter. Further research is needed with evolving technology to better understand smartphone pulse oximetry. (ClinicalTrials.gov registration NCT03534271.).

Dataset Information

The Use of Wearable Pulse Oximeters in the Prompt Detection of Hypoxemia and During Movement: Diagnostic Accuracy Study.

Background

Objective

Methods

Results

Conclusions

Trial registration

International registered report identifier (irrid)

Publications

The Use of Wearable Pulse Oximeters in the Prompt Detection of Hypoxemia and During Movement: Diagnostic Accuracy Study.

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