Catharina ziekenhuis Eindhoven
Eindhoven, North Brabant, 5623 EJ, Netherlands
NCT Number: NCT06099327
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.
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Notify Me18 year and older
All sexes
Observational
Eindhoven, North Brabant, 5623 EJ, Netherlands
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Unobtrusive, vital signs measurements with remote photoplethysmography
Time frame: 5-7 days
Percentage of signal loss can be due to artifacts as a result movement, lighting conditions, clinical interventions and time 'out of scope' of patients
Time frame: 5-7 days
Agreement of image-based heart- and respiration rate with healthdot data
Time frame: 5-7 days
Agreement of image-based carcadian rhythms with healthdot data
Time frame: 1 year5-7 days
Sensitivity/specificity of image-based data to predict clinical deterioration
Time frame: 5-7 days
Potential time gain as a result of image-based monitoring in detection of clinical deterioration
Time frame: 5-7 days
Added value of each image-based parameters in the detection of clinical deterioration
Time frame: 2 years
Association of occurence of postoperative complications with long term outcomes
Time frame: 5-7 days
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.
Catharina Ziekenhuis Eindhoven
Other
Image-based Remote Monitoring in Cardiac Surgery Patients: FORSEE 3 Trial
Acronym: FORSEE-3
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