ABSTRACT
Aims: The aim was to validate the performance of a monitoring system consisting of a wrist-worn device and a data management cloud service intended to be used by medical professionals in detecting atrial fibrillation (AF). Methods: Thirty adult patients diagnosed with AF alone or AF with concomitant flutter were recruited. Continuous photoplethysmogram (PPG) and intermittent 30 s Lead I electrocardiogram (ECG) recordings were collected over 48 h. The ECG was measured four times a day at prescheduled times, when notified due to irregular rhythm detected by PPG, and when self-initiated based on symptoms. Three-channel Holter ECG was used as the reference. Results: The subjects recorded a total of 1,415 h of continuous PPG data and 3.8 h of intermittent ECG data over the study period. The PPG data were analyzed by the system's algorithm in 5-min segments. The segments containing adequate amounts, at least ~30 s, of adequate quality PPG data for rhythm assessment algorithm, were included. After rejecting 46% of the 5-min segments, the remaining data were compared with annotated Holter ECG yielding AF detection sensitivity and specificity of 95.6 and 99.2%, respectively. The ECG analysis algorithm labeled 10% of the 30-s ECG records as inadequate quality and these were excluded from the analysis. The ECG AF detection sensitivity and specificity were 97.7 and 89.8%, respectively. The usability of the system was found to be good by both the study subjects and the participating cardiologists. Conclusion: The system comprising of a wrist device and a data management service was validated to be suitable for use in patient monitoring and in the detection of AF in an ambulatory setting.Clinical Trial Registration: ClinicalTrials.gov/, NCT05008601.
ABSTRACT
The aims were to prepare stable and well-dispersible pulmonary fine powders composed of combination drugs with different water solubility, to facilitate concomitant release of corticosteroid budesonide and short acting ß-agonist salbutamol sulphate and to improve the dissolution of the budesonide. The budesonide nanosuspensions were prepared by a wet milling which were mixed then with salbutamol sulphate, mannitol (bulking material) and leucine (coating material) for the preparation of micron-sized particles by an aerosol flow reactor wherein leucine formed a rough coating layer on particle surface. The stable and intact particle assemblies showed excellent aerosolization performance. The emitted doses from the inhaler, Easyhaler(®), were ~3 mg/dose with a coefficient variation of 0.1, and the fine particle fractions were ~50%. Complete dissolution of budesonide nanocrystals from the particles took place within 20 min with the same rate as salbutamol sulphate. Combining the two formulation technologies enabled the encapsulation of drugs with different solubility into a single, intact particle. The leucine coating provided excellent aerosolization properties which allowed fine powder delivery from the inhaler without carrier particles. This study showed the feasibility of preparing powders for combination therapy that are utilized, for instance, in inhalation therapy.
