Clinical validation of vital signs measured by the Vital Signs Monitoring System in a controlled environment

Current general ward monitoring protocols typically consist of intermittent
spot checks by a nurse about every 4*8*h. Changes in vital signs are a warning
sign of clinical deterioration, which are not always noticed by the spot
checks. To provide healthcare professionals with a method to frequently monitor
vital signs, FastFocus developed its second generation of a wireless monitoring
system, the Vital Signs Monitoring System. This wearable device combines
physical activity monitoring with the monitoring of vital signs and is,
therefore, feasible to be used on ambulant patients in a healthcare
environment. We want to evaluate the accuracy of the Vital Signs Monitoring
System to determine functional oxygen saturation and respiratory rate in a
clinical investigation. This is essential to assure its accuracy before
bringing the device to the market.

The main objectives of this study are to determine the accuracy of the device
(1) to determine functional oxygen saturation (SpO2) compared to a reference
device, and (2) to determine respiratory rate compared to visual observations.
As a secondary objective, the measured respiratory rate will be compared to a
reference device.

This study is a method-comparison study in a controlled environment. Healthy
volunteers will perform a controlled desaturation procedure and controlled
respiratory rate procedure while being monitored by the device under
investigation and a reference device. The respiratory rate will be observed
visually.

The subjects will undergo a controlled desaturation procedure and respiratory
rate procedure. Total participating time is approximately 2.5 hours (excluding
breaks between measurements).

Brief and profound hypoxia is well tolerated by healthy humans. Subjects might
experience a physical reaction to decreased oxygen saturation levels or
hyperventilation or other symptoms during increased respiratory rates. However,
these symptoms are reversible. In addition, subjects can stop at any moment
when they do not feel well. The subjects need approximately 2.5 hours to
participate in the study. Although, subjects will not experience any personal
benefit from participating in the study, their participation can help improve
the device which future patients can benefit of. The hardware of the device
under investigation is identical to another FastFocus device that is CE marked
as a medical device. In summary, it is concluded that the risk and burden for
participating in the study are low.