Image-based Remote Monitoring in Cardiac Surgery Patients

Study Overview
=================
Brief Summary
-----------------
In this observational study, 100 patients admitted to the Cardiothoracic ward will be additionally monitored with video-cameras. The video-cameras will measure heart- and respiration rate continuously. Other features, such a cardiac arrhythmias and context analysis may be added as well. Data will be analysed retrospectively and will be compared with vital parameters measured with healthdot- and spot check measurements.

Detailed Description
-----------------
Rationale: 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. Objective: 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. The purpose of this study is to evaluate the feasibility, in terms of system fidelity and acceptance, of long-term image-based monitoring in a cardiothoracic ward setting. Secondary objectives are to evaluate the validity of image-based vital signs and circadian rhythms in comparison with reference devices, the discriminative ability of image-based monitoring in the prediction of clinical deterioration and effect of clinical deterioration detected with remote monitoring during hospital admission on long-term patient outcomes. Study design: Observational study Study population: 100 cardiac surgery patients Main study parameters/endpoints: Primary endpoints are (1) insight in signal loss due to artifacts and time 'out of scope' of patients, (2) storage and processing solutions to enable conversion of large amounts of image-based data into vital signs and (3) level of acceptance by healthcare staff and patients. Secondary endpoints are performance of image-based vital signs and circadian rhythms in comparison with reference devices and sensitivity and specificity for the prediction of deterioration based on the image-based data. Moreover, potential time gain and predictive value of each image-based parameter will be assessed. Another secondary endpoint is insight in the relation of occurrence of clinical deterioration detected with the image-based monitoring technology during admission and long-term patient outcomes.

Official Title
-----------------
Image-based Remote Monitoring in Cardiac Surgery Patients: FORSEE 3 Trial

Conditions
-----------------
Clinical Deterioration, Vital Signs

Intervention / Treatment
-----------------
* Device: Image-based vital sign monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Willing and able to sign informed consent form Patients admitted to the cardio-thoracic ward postoperative after cardiac surgery Planned stay on the cardio-thoracic ward at least 48 hours Exclusion Criteria: Pregnant patients Inability to provide written informed consent Mental disability Language barrier Inability to wear Healthdot: known severe allergy for the tissue adhesive used in the Healthdot, any skin condition or use of topicals at the area of application of the Healthdot

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Postoperative after cardiac surgery<br>Patients after cardiac surgery will participate in the trial during their postoperative stay on the cardiothoracic ward. | Device: Image-based vital sign monitoring<br>* Unobtrusive, vital signs measurements with remote photoplethysmography<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of signal coverage of remote, image-based monitoring in cardiac surgery patients on a general ward | Percentage of signal loss can be due to artifacts as a result movement, lighting conditions, clinical interventions and time 'out of scope' of patients | 5-7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The validity of remote, image-based heart- and respiration rate in comparison with heart- and respiration rate measured with the Healthdot (smart patch) | Agreement of image-based heart- and respiration rate with healthdot data | 5-7 days | 
| The validity of remote, image-based monitoring of circadian rhythms in comparison with the Healthdot (smart patch) | Agreement of image-based carcadian rhythms with healthdot data | 5-7 days | 
| Discriminative ability of remote, image-based monitoring in the detection of clinical deterioration | Sensitivity/specificity of image-based data to predict clinical deterioration | 1 year5-7 days | 
| Time to detection of clinical deterioration with the image-based monitoring technology vs conventional early warning score (measured via the spot check approach) | Potential time gain as a result of image-based monitoring in detection of clinical deterioration | 5-7 days | 
| Predictive value of each image-based parameter in the detection of postoperative complications | Added value of each image-based parameters in the detection of clinical deterioration | 5-7 days | 
| Effect of clinical deterioration detected with image-based, remote monitoring during hospital admission on long term patient outcomes (mortality, complications) | Association of occurence of postoperative complications with long term outcomes | 2 years | 
| Invasion of privacy of image-based remote monitoring, experienced by patients and healthcare staff, presented on a likert scale (1 means no invasion of privacy at all and 5 serious invasion of privacy) | Invasion of privacy will be assessed with a questionnaire with a likert scale (1-5), 1 means no invasion of privacy at all and 5 serious invasion of privacy. | 5-7 days |