Skip to main content
OpenTrials
Completed

NCT Number: NCT05455775

Video Monitoring FOR Early Signaling of Adverse EvEnts, Technical Validation

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Catharina ziekenhuis Eindhoven

Eindhoven, North Brabant, 5623 EJ, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Camera-based monitoring technology

Device

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

Primary outcomes

  1. Validity of the camera-based signals

    Time frame: 24 hours

    Validity of the video based signal compared to the measured signal obtained with a contact sensor.

  2. Feasibility of the camera-based signals

    Time frame: 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 outcomes

  1. Insight in user and patient experience

    Time frame: Within 1 week after intervention

    Insight in user and patient experience with the camera-based monitoring technology

Sponsors and collaborators

Lead sponsor

Catharina Ziekenhuis Eindhoven

Other

Registry information

Acronym: FORSEE

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 13, 2022
Registry last updated
Feb 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.