Image-based Remote Monitoring in Cardiac Surgery Patients

NCT06099327 | Completed

• 1 other identifier: CZE-2023.28
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Vital Signs; Clinical Deterioration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

• The validity of remote, image-based monitoring of circadian rhythms in comparison with the Healthdot (smart patch)

  5-7 days

• Discriminative ability of remote, image-based monitoring in the detection of 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)

  5-7 days

• Predictive value of each image-based parameter in the detection of postoperative complications

  5-7 days

Study Arms (1)

Postoperative after cardiac surgery

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

Device: Image-based vital sign monitoring

Interventions

Image-based vital sign monitoring DEVICE

Unobtrusive, vital signs measurements with remote photoplethysmography

Postoperative after cardiac surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The intended population within this study will be cardiac surgery patients, admitted to the cardio-thoracic ward in the Catharina hospital, because they are at risk to develop postoperative complications. The research team will approach eligible patients who are scheduled to undergo cardiac surgery in collaboration with the cardio-thoracic surgeons. On average, 20 cardiac surgeries take place each week.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Catharina Ziekenhuis Eindhoven: lead
• Eindhoven University of Technology: collaborator

Study Sites (1)

Catharina ziekenhuis Eindhoven

Eindhoven, North Brabant, 5623 EJ, Netherlands

Location

MeSH Terms

Conditions

Clinical Deterioration

Condition Hierarchy (Ancestors)

Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lukas Dekker, Prof. dr.

  Catharina Ziekenhuis Eindhoven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: October 25, 2023
• Study Start: February 23, 2024
• Primary Completion: February 4, 2025
• Study Completion: February 4, 2025
• Last Updated: April 11, 2025

Record last verified: 2025-04

Locations

NL (1)