Image-based Remote Monitoring in Cardiac Surgery Patients

Vital Signs Clinical Trial

— FORSEE-3  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06099327
• Other study ID #: CZE-2023.28
• Status: Recruiting
• Start date: February 23, 2024
• Est. completion date: December 1, 2024

Study information

• Verified date: April 2024
• Source: Catharina Ziekenhuis Eindhoven
• Contact: Iris Cramer, MD
• Phone: +31630603665
• Email: Iris.cramer[@]catharinaziekenhuis.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Clinical Deterioration
• Vital Signs

Intervention

Device:
• Image-based vital sign monitoring
Unobtrusive, vital signs measurements with remote photoplethysmography

Locations

Country	Name	City	State
Netherlands	Catharina ziekenhuis Eindhoven	Eindhoven	Noord-brabant

Sponsors (2)

Lead Sponsor	Collaborator
Catharina Ziekenhuis Eindhoven	Eindhoven University of Technology

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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