Video Monitoring FOR Early Signaling of Adverse EvEnts, Technical Validation

Vital Signs Clinical Trial

— FORSEE  

Official title:

Video Monitoring FOR Early Signaling of Adverse EvEnts, Technical Validation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05455775
• Other study ID #: CatharinaZE
• Status: Completed
• Start date: August 3, 2022
• Est. completion date: August 24, 2023

Study information

• Verified date: February 2024
• Source: Catharina Ziekenhuis Eindhoven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 24, 2023
• Est. primary completion date: August 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vital Signs

Intervention

Device:
• Camera-based monitoring technology
Unobtrusive, vital sign measurement with remote photoplethysmography and laser speckle vibrometry

Locations

Country	Name	City	State
Netherlands	Catharina ziekenhuis Eindhoven	Eindhoven	Noord-brabant

Sponsors (1)

Lead Sponsor	Collaborator
Catharina Ziekenhuis Eindhoven

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validity of the camera-based signals	Validity of the video based signal compared to the measured signal obtained with a contact sensor.	24 hours
Primary	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	Insight in user and patient experience	Insight in user and patient experience with the camera-based monitoring technology	Within 1 week after intervention