Image-based Remote Monitoring in Cardiac Surgery Patients

Completed

• Conditions: Clinical Deterioration; Vital Signs

• Registration Number: NCT06099327
• Lead Sponsor: Catharina Ziekenhuis Eindhoven

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.

Study Timeline

• Study First Submitted: 2023-09-12
• Study First Submitted QC: 2023-10-23
• Study First Posted: 2023-10-25
• Study Start: 2024-02-23
• Primary Completion: 2025-02-04
• Study Completion: 2025-02-04
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of signal coverage of remote, image-based monitoring in cardiac surgery patients on a general ward	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

Secondary Outcome Measures

Name	Time	Method
The validity of remote, image-based heart- and respiration rate in comparison with heart- and respiration rate measured with the Healthdot (smart patch)	5-7 days	Agreement of image-based heart- and respiration rate with healthdot data
Time to detection of clinical deterioration with the image-based monitoring technology vs conventional early warning score (measured via the spot check approach)	5-7 days	Potential time gain as a result of image-based monitoring in detection of clinical deterioration
Predictive value of each image-based parameter in the detection of postoperative complications	5-7 days	Added value of each image-based parameters in the detection of clinical deterioration
Effect of clinical deterioration detected with image-based, remote monitoring during hospital admission on long term patient outcomes (mortality, complications)	2 years	Association of occurence of postoperative complications with long term outcomes
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)	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.
The validity of remote, image-based monitoring of circadian rhythms in comparison with the Healthdot (smart patch)	5-7 days	Agreement of image-based carcadian rhythms with healthdot data
Discriminative ability of remote, image-based monitoring in the detection of clinical deterioration	1 year5-7 days	Sensitivity/specificity of image-based data to predict clinical deterioration

Trial Locations

Locations (1)

Catharina ziekenhuis Eindhoven; 🇳🇱 Eindhoven, Noord-brabant, Netherlands