Title
MULTI-VITAL Multi Parameter Vital Signs Monitoring by the Corsano Cardiowatch 287-2 Validation Study

Rationale
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, although emerging, are often not clinically validated or limited to the monitoring of one or two vital signs.

Objective
This study aims to validate the Corsano CardioWatch 287-2 Bracelet 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; peripheral oxygen saturation at ≤ 3 percentage point RMSE; non-invasive blood pressure at ≤ 10 mmHg RMSE against a reference device.

Study design
The study is a single center, single arm prospective study

Study population
Study participants will be drawn from patients undergoing heart catheterization exam in the Reinier de Graaf Gasthuis

Intervention (if applicable)
The Corsano CardioWatch 287-2 will be put on the patient’s wrist, enabling the measurement of pulse variations. Continuous blood pressure measurements are recorded during the phase that indwelling arterial catheters are present for angiography. Besides, non-invasive blood pressure, peripheral oxygen saturation, heart rate and respiration rate will be measured by a reference device.

Main study parameters/endpoints
Root mean squared error between measurements recorded by Corsano CardioWatch 287-2 and reference device.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness

Patients will be asked for informed consent. If consent is provided, the patient will be put on the Corsano CardioWatch 287-2 right before the 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, directly. There will be no follow-up.

Number of Participants
160 patients at the catheterization laboratory of Reinier de Graaf Gasthuis Delft during catheterization exam, measurements will take place by the Corsano CardioWatch 287-2 and a reference device.

Inclusion / Exclusion criteria

Inclusion criteria:
≥ 18 years old;
undergoing coronary angiography;
able to provide consent

Exclusion criteria:
who cannot wear the Corsano CardioWatch 287 due to reasons such as allergic reactions, wounds, amputations etc.;
unable or not willing to sign informed consent;
with significant mental or cognitive impairment;
who do not have a suitable entry site for the invasive arterial line.

Study Centre
Reinier de Graaf Gasthuis Delft (NL)

Start time, Duration
November 2021, 14 months

https://clinicaltrials.gov/ct2/show/NCT05566886