Video Monitoring FOR Early Signaling of Adverse EvEnts, Technical Validation

NCT ID: NCT05455775

Last Updated: 2024-02-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 36 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-03
• Study Completion Date: 2023-08-24

Brief Summary

In this study, 30 patients admitted to an high acuity department with hemodynamic or respiratory pathologies will be monitored with camera-based monitoring technologies for 24 hours. The camera's will measure heart rate and respiration rate, based on the principle of remote photoplethysmography and laser speckle vibrometry. Data will be analysed retrospectively and will be compared with vital parameters measured with the standard patient monitor.

Detailed Description

Rationale: In hospitals, some 40% 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 cost that deployment of such technologies would entail.

Objective: This project explores video monitoring of the cardiorespiratory status of the patient as an innovative unobtrusive method that could eventually aid to reduce workload for the staff and better predict (acute) deterioration or adverse cardiac events. The objective of this study is to determine the accuracy and validity of the camera-based vital parameters with respect to the measured contact sensors in intensive care unit (ICU) patients.

Study design: Observational study

Study population: Patients with cardiorespiratory pathologies on the ICU.

Main study parameters/endpoints: The primary end-point is the reliability of the video monitoring technology (remote photoplethysmography and speckle vibrometry) compared with contact sensors focusing on heart rate and respiratory rate in a clinical setting. User experience will have a continuous focus during this study.

Conditions

Vital Signs

Study Design

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

Interventions

Camera-based monitoring technology

Unobtrusive, vital sign measurement with remote photoplethysmography and laser speckle vibrometry

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients admitted to an high acuity unit with a planned stay of at least 4 hours
• Patients with cardiorespiratory pathologies
• Age >= 18

Exclusion Criteria

• Pregnant patients
• Inability to provide written informed consent
• Mental disability
• Language barrier

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

Sponsors

Catharina Ziekenhuis Eindhoven

OTHER

Sponsor Role: lead

Responsible Party

Lukas Dekker

Prof. dr. L.R.C. Dekker

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lukas Dekker

Role: PRINCIPAL_INVESTIGATOR

Catharina Ziekenhuis Eindhoven

Locations

Catharina ziekenhuis Eindhoven

Eindhoven, North Brabant, Netherlands

Countries

Netherlands

Other Identifiers

CatharinaZE

Identifier Type: -

Identifier Source: org_study_id