Image-based Remote Monitoring in Cardiac Surgery Patients

NCT ID: NCT06099327

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-23
• Study Completion Date: 2025-02-04

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.

Conditions

Vital Signs; Clinical Deterioration

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Postoperative after cardiac surgery

Patients after cardiac surgery will participate in the trial during their postoperative stay on the cardiothoracic ward.

Image-based vital sign monitoring

Intervention Type: DEVICE

Unobtrusive, vital signs measurements with remote photoplethysmography

Interventions

Image-based vital sign monitoring

Unobtrusive, vital signs measurements with remote photoplethysmography

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eindhoven University of Technology

OTHER

Sponsor Role: collaborator

Catharina Ziekenhuis Eindhoven

OTHER

Sponsor Role: lead

Responsible Party

Lukas Dekker

Prof. dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lukas Dekker, Prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Catharina Ziekenhuis Eindhoven

Locations

Catharina ziekenhuis Eindhoven

Eindhoven, North Brabant, Netherlands

Countries

Netherlands

Other Identifiers

CZE-2023.28

Identifier Type: -

Identifier Source: org_study_id