Background Clinical trial guidelines for assessing the safety of vaccines, are primarily based on self-reported questionnaires. Despite the tremendous technological advances in recent years, objective, continuous assessment of physiological measures post-vaccination is rarely performed. Methods We conducted a prospective observational study during the mass vaccination campaign in Israel. 160 participants >18 years who were not previously found to be COVID-19 positive and who received the BNT162b2 COVID-19 (Pfizer BioNTech) vaccine were equipped with an FDA-approved chest-patch sensor and a dedicated mobile application. The chest-patch sensor continuously monitored 13 different cardiovascular, and hemodynamic vitals: heart rate, blood oxygen saturation, respiratory rate, systolic and diastolic blood pressure, pulse pressure, mean arterial pressure, heart rate variability, stroke volume, cardiac output, cardiac index, systemic vascular resistance and skin temperature. The mobile application collected daily self-reported questionnaires on local and systemic reactions. Results We identify continuous and significant changes following vaccine administration in nearly all vitals. Markedly, these changes are observed even in presumably asymptomatic participants who did not report any local or systemic reaction. Changes in vitals are more apparent at night, in younger participants, and in participants following the second vaccine dose. Conclusion the considerably higher sensitivity of wearable sensors can revolutionize clinical trials by enabling earlier identification of abnormal reactions with fewer subjects.
COVID-19 exerts deleterious cardiopulmonary effects, leading to a worse prognosis in the most affected. This retrospective multi-center observational cohort study aimed to analyze the trajectories of key vitals amongst hospitalized COVID-19 patients using a chest-patch wearable providing continuous remote patient monitoring of numerous vital signs. The study was conducted in five COVID-19 isolation units. A total of 492 COVID-19 patients were included in the final analysis. Physiological parameters were measured every 15 min. More than 3 million measurements were collected including heart rate, systolic and diastolic blood pressure, cardiac output, cardiac index, systemic vascular resistance, respiratory rate, blood oxygen saturation, and body temperature. Cardiovascular deterioration appeared early after admission and in parallel with changes in the respiratory parameters, showing a significant difference in trajectories within sub-populations at high risk. Early detection of cardiovascular deterioration of COVID-19 patients is achievable when using frequent remote patient monitoring.
Introduction Ischemic preconditioning (IPC) before exercise has been shown to be a novel approach to improve performance in different exercise modes in normoxia (NORM). Few studies have been conducted examining potential mechanisms behind these improvements, and less has been done examining its influence during exercise in hypoxia (HYP). Oxygen uptake and extraction kinetics are factors that have been implicated as possible determinants of cycling performance. We hypothesized that IPC would lead to improvements in oxygen extraction and peripheral blood flow kinetics, and this would translate to improvements in cycling time trial (TT) performance in both NORM and HYP. Methods Thirteen men (age, 24 ± 7 yr; V˙O2max, 63.1 ± 5.1 mL·kg−1·min−1) participated in the study. Subjects completed trials of each combination of normobaric HYP (FiO2 = 0.16, simulating ~8000 ft/2500 m) or NORM (FiO2 = 0.21) with preexercise IPC protocol (4 × 5 min at 220 mm Hg) or SHAM procedure. Trials included submaximal constant load cycle exercise bouts (power outputs of 15% below gas exchange threshold, and 85% of V˙O2max), and a 5-km cycling performance TT. Results Ischemic preconditioning significantly improved 5-km TT time in NORM by 0.9% ± 1.8% compared with SHAM (IPC, 491.2 ± 35.2 s vs SHAM, 495.9 ± 36.0 s; P < 0.05). Ischemic preconditioning did not alter 5-km TT performance times in HYP (P = 0.231). Ischemic preconditioning did, however, improve tissue oxygen extraction in HYP (deoxygenated hemoglobin/myoglobin: IPC, 21.23 ± 10.95 μM; SHAM, 19.93 ± 9.91 μM; P < 0.05) during moderate-intensity exercise. Conclusions Our data confirm that IPC is an effective ergogenic aid for athletes performing 5-km cycling TT bouts in NORM. Ischemic preconditioning did mitigate the declines in tissue oxygen during moderate-intensity exercise in HYP, but this did not translate to a significant effect on mean group performance. These data suggest that IPC may be of benefit for athletes training and competing in NORM.
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