Video Monitoring FOR Early Signaling of Adverse EvEnts, Technical Validation (FORSEE)

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.

Study Overview

• Status: Completed
• Conditions: Vital Signs
• Intervention / Treatment: Device: Camera-based monitoring technology

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 Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• Netherlands
  • Noord-brabant
    • Eindhoven, Noord-brabant, Netherlands, 5623 EJ
      • Catharina ziekenhuis Eindhoven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The intended population within this pilot study will be patients with cardiorespiratory pathologies that are expected to be monitored for at least 4 hours in an high acuity department, which means the Intensive Care Unit, the Medium Care unit or the Coronary Care Unit. This population will be monitored extensively with contact sensors that will serve as the reference to the video-based signals. Most of the patients will recover without any adverse events but some might experience an (acute) cardiorespiratory event (i.e. hemodynamic deterioration).

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insight in user and patient experience	Insight in user and patient experience with the camera-based monitoring technology	Within 1 week after intervention

Collaborators and Investigators

• Sponsor: Catharina Ziekenhuis Eindhoven
• Investigators: Principal Investigator: Lukas Dekker, Catharina ziekenhuis Eindhoven

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2022
• Primary Completion (Actual): August 24, 2023
• Study Completion (Actual): August 24, 2023

Study Registration Dates

• First Submitted: July 8, 2022
• First Submitted That Met QC Criteria: July 8, 2022
• First Posted (Actual): July 13, 2022

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CatharinaZE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No