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

Sponsor
Catharina Ziekenhuis Eindhoven (Other)
Overall Status
Recruiting
CT.gov ID
NCT05455775
Collaborator
(none)
30
1
4.9
6.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
30 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Video Monitoring FOR Early Signaling of Adverse EvEnts, Technical Validation
Actual Study Start Date :
Aug 3, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Outcome Measures

Primary Outcome Measures

  1. Validity of the camera-based signals [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 [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

  1. Insight in user and patient experience [Within 1 week after intervention]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Catharina ziekenhuis Eindhoven Eindhoven Noord-brabant Netherlands 5623 EJ

Sponsors and Collaborators

  • Catharina Ziekenhuis Eindhoven

Investigators

  • Principal Investigator: Lukas Dekker, Catharina Ziekenhuis Eindhoven

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lukas Dekker, Prof. dr. L.R.C. Dekker, Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier:
NCT05455775
Other Study ID Numbers:
  • CatharinaZE
First Posted:
Jul 13, 2022
Last Update Posted:
Aug 9, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 9, 2022