Video Monitoring FOR Early Signaling of Adverse EvEnts, Technical Validation

Completed

• Conditions: Vital Signs

• Registration Number: NCT05455775
• Lead Sponsor: Catharina Ziekenhuis Eindhoven

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.

Study Timeline

• Study First Submitted: 2022-07-08
• Study First Submitted QC: 2022-07-08
• Study First Posted: 2022-07-13
• Study Start: 2022-08-03
• Primary Completion: 2023-08-24
• Study Completion: 2023-08-24
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-09
• Last Update Posted: 2024-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Validity of the camera-based signals	24 hours	Validity of the video based signal compared to the measured signal obtained with a contact sensor.
Feasibility of the camera-based signals	24 hours	Feasibility of the video based signal compared to the measured signal obtained with a contact sensor, expressed as percentage of data loss.

Secondary Outcome Measures

Name	Time	Method
Insight in user and patient experience	Within 1 week after intervention	Insight in user and patient experience with the camera-based monitoring technology

Trial Locations

Locations (1)

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