Image-based remote monitoring in cardiac surgery patients: FORSEE 3 trial

In hospitals forty percent of unanticipated deaths occur in low-acuity
departments. This alarming figure reflects the limited degree to which the
cardiorespiratory status of patients is monitored in these departments, due to
the obtrusiveness and expense of existing monitoring technologies, as well as
the unpractically high clinical workload and costs that deployment of such
technologies would entail. We have previously shown that an image-based
monitoring technology reliably estimates heart rhythm and breathing rate under
controlled conditions. This project explores image-based monitoring of the
cardiorespiratory status of patients as an innovative unobtrusive method that
could eventually aid to reduce workload for the staff and better predict
(acute) deterioration or adverse events.

Main objective:
1. Determine the feasibility, in terms of system fidelity and acceptability, of
remote, image-based monitoring in cardiac surgery patients on a general ward.

Secondary objectives:
1. The validity of remote, image-based heart- and respiration rate in
comparison with heart- and respiration rate measured with a smart patch
2. The validity of remote, image-based monitoring of circadian rhythms in
comparison with a smart patch
3. Discriminative ability of remote, image-based monitoring in the detection of
clinical deterioration
4. Time to detection of clinical deterioration with the image-based monitoring
technology vs conventional early warning score
5. Predictive value of each camera-based parameter in the detection of
postoperative complications
a) Heart rate
b) Respiration rate
c) Arrhythmia yes/no
d) Facial colour (changes) and potentially other facial cues of illness
e) Temperature changes
f) Time in bed
g) Activity level/ consciousness scale
6. Effect of clinical deterioration detected with image-based, remote
monitoring during hospital admission on long term patient outcomes (mortality,
complications)

This is a prospective, observational study in the Catharina hospital,
Eindhoven. Patients postoperative after cardiac surgery will be asked to add
the camera set-up to their hospital room during their hospital stay.
Furthermore, they will wear a smart patch, Healthdot, as CE marked reference
device. The study will neither impact the standard of care, nor are the
participants subject to procedures or required to follow any rules of behavior.
All data will be analyzed retrospectively, and no medical decisions will be
made based on the study data. After 12 months, Nederlandse Hart Registratie
(NHR) data of study participants will be collected, concerning long-term
patient outcomes.

Since the proposed technology is completely non-obtrusive there is no
additional risk related for the study patients related to the device used.
Eventually, when applied in the future, the unobtrusiveness of this technology
will increase comfort for patients and reduces workload for the nursing staff.
The technique has the potential to support Value-Based HealthCare principles,
as it is expected to reduce unexpected adverse events, better risk prediction,
shorter hospital stays and increased patient wellbeing by freeing up staff time
for the patient.