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Healthdot 3.1 whitepaper

Mar 19, 2025
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1 minuten

Clinical Validation of Pulse Rate and Breathing Rate Measurements Provided by Healthdot in Bariatric and Oncology Patients: Interim Results from the TRICA Study.

Background

Cardiac pulse rate (PR) and breathing rate (BR) are essential vital signs for patient monitoring and early deterioration detection. Continuous and unobtrusive monitoring of these parameters can enhance clinical decision-making. Healthdot is a wearable remote patient monitoring (RPM) solution designed to provide continuous measurements of PR and BR. This study aimed to validate the accuracy of Healthdot measurements against clinical reference standards in a post-surgical setting.

Objective

The study's primary goal was to assess the accuracy of Healthdot's PR and BR measurements compared to clinical references, such as ECG for PR and capnography for BR. The secondary objective was to determine the reliability of Healthdot data in a clinical environment.

Methods

A cohort of 39 post-surgical patients (26 bariatric surgery, 13 oncology surgery) participated in this study, conducted as part of the TRICA trial. Patients were monitored in a post-anesthesia care unit, with Healthdot placed on the lower-left rib of the chest. Data collection occurred in parallel with clinical monitoring systems (Philips and GE patient monitors).

Healthdot measured PR and BR continuously, storing data at short intervals and transmitting a 5-minute average to a backend system via a low-power wide-area network (LoRa). The accuracy of PR and BR readings was assessed through time-synchronized comparisons with clinical reference data.

Results

Pulse Rate (PR):

  • Average error: 0.67 bpm
  • 89% of measurements had an error <3 bpm
  • Strong correlation with ECG reference

Breathing Rate (BR):

  • Average error: -0.37 brpm
  • 93% of measurements had an error <3 brpm
  • High reliability compared to capnography reference


Bland-Altman plots confirmed the strong agreement between Healthdot and the clinical reference measurements.

Conclusion

Healthdot demonstrated high accuracy in PR and BR measurements, making it a reliable solution for continuous remote monitoring in clinical settings. By providing validated data comparable to gold-standard clinical devices, Healthdot has the potential to enhance patient care, particularly in post-surgical recovery and home-based monitoring scenarios.

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