Clinical validation of a wearable respiratory rate device: A brief report
Arik Eisenkraft, Nir Goldstein, Arik Ben Ishay, Meir Fons, Michael Tabi, Anna Danielle Sherman, Roei Merin, Dean Nachman- Pulmonary and Respiratory Medicine
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.
Trial registration
ClinicalTrials.gov , https://clinicaltrials.gov/ct2/show/NCT03603860 .