Vital SignsFORSEENCT05455775
Video Monitoring FOR Early Signaling of Adverse EvEnts, Technical Validation
An observational study of Vital Signs, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vital Signs
- What is being tested?
- Camera-based monitoring technology
- Type of treatment
- Medical device
- How many people
- 36 participants
- Where
- 1 siteNetherlands
- Study dates
- 3 Aug 2022to 24 Aug 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- Patients admitted to an high acuity unit with a planned stay of at least 4 hours
- Patients with cardiorespiratory pathologies
- Age >= 18
Who cannot join
- Pregnant patients
- Inability to provide written informed consent
- Mental disability
- Language barrier
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Catharina ziekenhuis Eindhoven
Eindhoven, North Brabant, 5623 EJ
About this study
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.
Read the 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.
- Conditions
- Vital Signs
- Being tested
- Camera-based monitoring technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camera-based monitoring technologyDevice
Unobtrusive, vital sign measurement with remote photoplethysmography and laser speckle vibrometry
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity of the camera-based signals
Validity of the video based signal compared to the measured signal obtained with a contact sensor.
Measured: 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.
Measured: 24 hours
Secondary outcomes (1)
Insight in user and patient experience
Insight in user and patient experience with the camera-based monitoring technology
Measured: Within 1 week after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start3 Aug 2022
- Primary completion24 Aug 2023
- Study completion24 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vital SignsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lukas Dekker, Catharina Ziekenhuis Eindhoven
- Investigators
- Lukas Dekker, Principal investigator, Catharina Ziekenhuis Eindhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05455775
- Sponsor's protocol ID
- CatharinaZE
- Acronym
- FORSEE
- Status last verified
- Feb 2024
- First submitted
- 8 Jul 2022
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Monitoring FOR Early Signaling of Adverse EvEnts, Technical Validation
- ClinicalTrials.gov ID
- NCT05455775
- Acronym / sponsor ID
- FORSEE / CatharinaZE
- Conditions
- Vital Signs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Study start
- 3 Aug 2022 (actual)
- Primary completion
- 24 Aug 2023 (actual)
- Study completion
- 24 Aug 2023 (actual)
- First posted
- 13 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- Patients admitted to an high acuity unit with a planned stay of at least 4 hours
- Patients with cardiorespiratory pathologies
- Age >= 18
Key exclusion criteria (4 listed)
- Pregnant patients
- Inability to provide written informed consent
- Mental disability
- Language barrier
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Camera-based monitoring technologyUnobtrusive, vital sign measurement with remote photoplethysmography and laser speckle vibrometry | Device | – |
Primary outcome
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.
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.
1 secondary outcome
Insight in user and patient experience
Time frame: Within 1 week after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Vital Signs
Not yet recruitingPhase 2
Validation & Intervention Testing for Aging, Longevity and Healthspan
Aging, Functional Decline
Recruiting
Effect of Mandala Coloring on Anxiety, Pain, Vital Signs, and Patient Satisfaction in Patients Undergoing Transurethral Resection of the Prostate
Mandala Coloring
RecruitingObservational study
Real-world Study of Nerandomilast in Patients With Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis
Not yet recruiting
Effect of Nurse-Directed Therapeutic Positioning in Children With Pneumonia
Pediatric Pneumonia
Not yet recruiting
Therapeutic Holding Versus Traditional Restraint During Pediatric Venipuncture
Pediatric Venipuncture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lukas Dekker principal investigator
Catharina Ziekenhuis Eindhoven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vital Signs, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity of the camera-based signals (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2024.