Video Monitoring FOR Early Signaling of Adverse EvEnts, Technical Validation

NCT05455775 | Completed

• 1 other identifier: CatharinaZE
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Vital Signs

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Insight in user and patient experience

  Within 1 week after intervention

Interventions

Camera-based monitoring technology DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Catharina Ziekenhuis Eindhoven: lead

Study Sites (1)

Catharina ziekenhuis Eindhoven

Eindhoven, North Brabant, 5623 EJ, Netherlands

Location

Study Officials

• Lukas Dekker

  Catharina Ziekenhuis Eindhoven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr. L.R.C. Dekker

Study Record Dates

• First Submitted: July 8, 2022
• First Posted: July 13, 2022
• Study Start: August 3, 2022
• Primary Completion: August 24, 2023
• Study Completion: August 24, 2023
• Last Updated: February 12, 2024

Record last verified: 2024-02

Locations

NL (1)