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Video Monitoring FOR Early Signaling of Adverse EvEnts, Technical Validation

Video Monitoring FOR Early Signaling of Adverse EvEnts, Technical Validation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05455775
Acronym
FORSEE
Enrollment
36
Registered
2022-07-13
Start date
2022-08-03
Completion date
2023-08-24
Last updated
2024-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vital Signs

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.

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.

Interventions

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

Sponsors

Catharina Ziekenhuis Eindhoven
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Validity of the camera-based signals24 hoursValidity of the video based signal compared to the measured signal obtained with a contact sensor.
Feasibility of the camera-based signals24 hoursFeasibility of the video based signal compared to the measured signal obtained with a contact sensor, expressed as percentage of data loss.

Secondary

MeasureTime frameDescription
Insight in user and patient experienceWithin 1 week after interventionInsight in user and patient experience with the camera-based monitoring technology

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026