Multiparameter vital signs monitoring validation of the Corsano CardioWatch 287-2

Today, continuous monitoring of vital signs remains a challenge since it
generally requires the patient to be connected to multiple wired sensors, which
restricts patient mobility in the intra-mural setting and complicates home
monitoring in the extra-mural setting. Wearable devices on the wrist, although
emerging, are often not clinically validated or limited to the monitoring of
one or two vital signs.

This study aims to validate the Corsano CardioWatch 287-2 for the continuous
monitoring of heart rate at <= 4 bpm root mean squared error (RMSE); interbeat
intervals at <= 50 ms RMSE; breathing rate at <= 2 brpm RMSE; and peripheral
oxygen saturation at <= 3 percentage point RMSE. Also, this study aims to
validate the Corsano CardioWatch 287-2 for the measurement of non-invasive
blood pressure according to ISO 81060-2:2018.

The study is a single center, single arm prospective study.
Summarizing, in patients being monitored intra-arterially, the Corsano
CardioWatch 287-2 wristband will be placed on the patient*s wrist, enabling the
comparison between wristband-data and data from routine monitoring.
Measurements for the trial encompass standardized hemodynamic measurements.
These consist of invasive and non-invasive blood pressure recordings,
peripheral oxygen saturation, heart rate and respiration rate by a reference
device.
In the catheterization room, measurements will be taken throughout the
procedure (+/- 20 minutes) without intervening in the procedure itself. At
three moments during the procedure, no actions will be performed for 60 seconds
in order to get a clean measurement signal.

Patients will be asked for informed consent. If consent is provided, the
patient will be put on the Corsano CardioWatch 287-2 during invasive arterial
monitoring like heart catherization examination. Besides, the patient will be
connected to sensors from a reference monitoring device. When the procedure is
finished, the Corsano CardioWatch 287-2 and the sensors will be removed. There
will be no follow-up.
The risks carried by this study are very low, considering the non-intrusiveness
of the investigative device and the conventional sensors of the reference
device. This study will not intervene in any medical intervention. In the heart
catheterization room, during 3 moments of 60 seconds the procedure will be
paused in order to obtain a clean measurement signal. The cardiologist will
determine which moments are safest for this. In the intensive care unit, the
measurements will always be subordinated to clinical interventions of the nurse
or doctor. The measurements can be paused for any moment when this is requested
by the nurse or doctor.
Study participants will have no direct benefit from participating to the trial.
However, when the Corsano CardioWatch 287-2 has been validated, the patient
population involved in this trial will benefit from a continuous monitoring
device that is considerably less intrusive than conventional monitoring
devices. This will facilitate long-term continuous intra- and extramural
monitoring of vital signs.