Vital SignsFORSEE-3NCT06099327
Image-based Remote Monitoring in Cardiac Surgery Patients
An observational study of Vital Signs and Clinical Deterioration, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
Trial summary
In this observational study, 100 patients admitted to the Cardiothoracic ward will be additionally monitored with video-cameras. The video-cameras will measure heart- and respiration rate continuously. Other features, such a cardiac arrhythmias and context analysis may be added as well. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vital Signs, Clinical Deterioration
- What is being tested?
- Image-based vital sign monitoring
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- 23 Feb 2024to 4 Feb 2025
- 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 study will be cardiac surgery patients, admitted to the cardio-thoracic ward in the Catharina hospital, because they are at risk to develop postoperative complications. The research team will approach eligible patients who are scheduled to undergo cardiac surgery in collaboration with the cardio-thoracic surgeons. On average, 20 cardiac surgeries take place each week.
Who may be able to join
- Age ≥ 18 years
- Willing and able to sign informed consent form
- Patients admitted to the cardio-thoracic ward postoperative after cardiac surgery
- Planned stay on the cardio-thoracic ward at least 48 hours
Who cannot join
- Pregnant patients
- Inability to provide written informed consent
- Mental disability
- Language barrier
- Inability to wear Healthdot: known severe allergy for the tissue adhesive used in the Healthdot, any skin condition or use of topicals at the area of application of the Healthdot
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Catharina ziekenhuis Eindhoven
Eindhoven, North Brabant, 5623 EJ
About this study
Official title: Image-based Remote Monitoring in Cardiac Surgery Patients: FORSEE 3 Trial
In this observational study, 100 patients admitted to the Cardiothoracic ward will be additionally monitored with video-cameras. The video-cameras will measure heart- and respiration rate continuously. Other features, such a cardiac arrhythmias and context analysis may be added as well. Data will be analysed retrospectively and will be compared with vital parameters measured with healthdot- and spot check measurements.
Read the detailed description
Rationale: In hospitals forty percent 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 costs that deployment of such technologies would entail. We have previously shown that an image-based monitoring technology reliably estimates heart rhythm and breathing rate under controlled conditions.
Objective: This project explores image-based monitoring of the cardiorespiratory status of patients as an innovative unobtrusive method that could eventually aid to reduce workload for the staff and better predict (acute) deterioration or adverse events. The purpose of this study is to evaluate the feasibility, in terms of system fidelity and acceptance, of long-term image-based monitoring in a cardiothoracic ward setting. Secondary objectives are to evaluate the validity of image-based vital signs and circadian rhythms in comparison with reference devices, the discriminative ability of image-based monitoring in the prediction of clinical deterioration and effect of clinical deterioration detected with remote monitoring during hospital admission on long-term patient outcomes.
Study design: Observational study Study population: 100 cardiac surgery patients
Main study parameters/endpoints: Primary endpoints are (1) insight in signal loss due to artifacts and time 'out of scope' of patients, (2) storage and processing solutions to enable conversion of large amounts of image-based data into vital signs and (3) level of acceptance by healthcare staff and patients. Secondary endpoints are performance of image-based vital signs and circadian rhythms in comparison with reference devices and sensitivity and specificity for the prediction of deterioration based on the image-based data. Moreover, potential time gain and predictive value of each image-based parameter will be assessed. Another secondary endpoint is insight in the relation of occurrence of clinical deterioration detected with the image-based monitoring technology during admission and long-term patient outcomes.
- Conditions
- Vital Signs, Clinical Deterioration
- Being tested
- Image-based vital sign monitoring
- Medical subject headings
- Clinical Deterioration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Image-based vital sign monitoringDevice
Unobtrusive, vital signs measurements with remote photoplethysmography
| Study group | Role | What they receive |
|---|---|---|
| Postoperative after cardiac surgery | Patients after cardiac surgery will participate in the trial during their postoperative stay on the cardiothoracic ward. Receives: Device: Image-based vital sign monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of signal coverage of remote, image-based monitoring in cardiac surgery patients on a general ward
Percentage of signal loss can be due to artifacts as a result movement, lighting conditions, clinical interventions and time 'out of scope' of patients
Measured: 5-7 days
Secondary outcomes (7)
The validity of remote, image-based heart- and respiration rate in comparison with heart- and respiration rate measured with the Healthdot (smart patch)
Agreement of image-based heart- and respiration rate with healthdot data
Measured: 5-7 days
The validity of remote, image-based monitoring of circadian rhythms in comparison with the Healthdot (smart patch)
Agreement of image-based carcadian rhythms with healthdot data
Measured: 5-7 days
Discriminative ability of remote, image-based monitoring in the detection of clinical deterioration
Sensitivity/specificity of image-based data to predict clinical deterioration
Measured: 1 year5-7 days
Time to detection of clinical deterioration with the image-based monitoring technology vs conventional early warning score (measured via the spot check approach)
Potential time gain as a result of image-based monitoring in detection of clinical deterioration
Measured: 5-7 days
Predictive value of each image-based parameter in the detection of postoperative complications
Added value of each image-based parameters in the detection of clinical deterioration
Measured: 5-7 days
Effect of clinical deterioration detected with image-based, remote monitoring during hospital admission on long term patient outcomes (mortality, complications)
Association of occurence of postoperative complications with long term outcomes
Measured: 2 years
Invasion of privacy of image-based remote monitoring, experienced by patients and healthcare staff, presented on a likert scale (1 means no invasion of privacy at all and 5 serious invasion of privacy)
Invasion of privacy will be assessed with a questionnaire with a likert scale (1-5), 1 means no invasion of privacy at all and 5 serious invasion of privacy.
Measured: 5-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start23 Feb 2024
- Primary completion4 Feb 2025
- Study completion4 Feb 2025
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Collaborators
- Eindhoven University of Technology
- Responsible party
- Principal investigator, Lukas Dekker, Catharina Ziekenhuis Eindhoven
- Investigators
- Lukas Dekker, Prof. dr., Principal investigator, Catharina Ziekenhuis Eindhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099327
- Sponsor's protocol ID
- CZE-2023.28
- Acronym
- FORSEE-3
- Status last verified
- Apr 2025
- First submitted
- 12 Sep 2023
- Last updated
- 11 Apr 2025
- 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 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image-based Remote Monitoring in Cardiac Surgery Patients: FORSEE 3 Trial
- ClinicalTrials.gov ID
- NCT06099327
- Acronym / sponsor ID
- FORSEE-3 / CZE-2023.28
- Conditions
- Vital Signs, Clinical Deterioration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Collaborators
- Eindhoven University of Technology
- Study start
- 23 Feb 2024 (actual)
- Primary completion
- 4 Feb 2025 (actual)
- Study completion
- 4 Feb 2025 (actual)
- First posted
- 25 Oct 2023 (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 observational study, 100 patients admitted to the Cardiothoracic ward will be additionally monitored with video-cameras. The video-cameras will measure heart- and respiration rate continuously. Other features, such a cardiac arrhythmias and context analysis may be added as well. Data will be analysed retrospectively and will be compared with vital parameters measured with healthdot- and spot check measurements.
Detailed description
Rationale: In hospitals forty percent 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 costs that deployment of such technologies would entail. We have previously shown that an image-based monitoring technology reliably estimates heart rhythm and breathing rate under controlled conditions.
Objective: This project explores image-based monitoring of the cardiorespiratory status of patients as an innovative unobtrusive method that could eventually aid to reduce workload for the staff and better predict (acute) deterioration or adverse events. The purpose of this study is to evaluate the feasibility, in terms of system fidelity and acceptance, of long-term image-based monitoring in a cardiothoracic ward setting. Secondary objectives are to evaluate the validity of image-based vital signs and circadian rhythms in comparison with reference devices, the discriminative ability of image-based monitoring in the prediction of clinical deterioration and effect of clinical deterioration detected with remote monitoring during hospital admission on long-term patient outcomes.
Study design: Observational study Study population: 100 cardiac surgery patients
Main study parameters/endpoints: Primary endpoints are (1) insight in signal loss due to artifacts and time 'out of scope' of patients, (2) storage and processing solutions to enable conversion of large amounts of image-based data into vital signs and (3) level of acceptance by healthcare staff and patients. Secondary endpoints are performance of image-based vital signs and circadian rhythms in comparison with reference devices and sensitivity and specificity for the prediction of deterioration based on the image-based data. Moreover, potential time gain and predictive value of each image-based parameter will be assessed. Another secondary endpoint is insight in the relation of occurrence of clinical deterioration detected with the image-based monitoring technology during admission and long-term patient outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postoperative after cardiac surgery | – | Device: Image-based vital sign monitoringPatients after cardiac surgery will participate in the trial during their postoperative stay on the cardiothoracic ward. |
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 study will be cardiac surgery patients, admitted to the cardio-thoracic ward in the Catharina hospital, because they are at risk to develop postoperative complications. The research team will approach eligible patients who are scheduled to undergo cardiac surgery in collaboration with the cardio-thoracic surgeons. On average, 20 cardiac surgeries take place each week.
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Willing and able to sign informed consent form
- Patients admitted to the cardio-thoracic ward postoperative after cardiac surgery
- Planned stay on the cardio-thoracic ward at least 48 hours
Key exclusion criteria (5 listed)
- Pregnant patients
- Inability to provide written informed consent
- Mental disability
- Language barrier
- Inability to wear Healthdot: known severe allergy for the tissue adhesive used in the Healthdot, any skin condition or use of topicals at the area of application of the Healthdot
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 |
|---|---|---|
| Image-based vital sign monitoringUnobtrusive, vital signs measurements with remote photoplethysmography | Device | Postoperative after cardiac surgery |
Primary outcome
Percentage of signal coverage of remote, image-based monitoring in cardiac surgery patients on a general ward
Time frame: 5-7 days
Percentage of signal loss can be due to artifacts as a result movement, lighting conditions, clinical interventions and time 'out of scope' of patients
7 secondary outcomes
The validity of remote, image-based heart- and respiration rate in comparison with heart- and respiration rate measured with the Healthdot (smart patch)
Time frame: 5-7 days
The validity of remote, image-based monitoring of circadian rhythms in comparison with the Healthdot (smart patch)
Time frame: 5-7 days
Discriminative ability of remote, image-based monitoring in the detection of clinical deterioration
Time frame: 1 year5-7 days
Time to detection of clinical deterioration with the image-based monitoring technology vs conventional early warning score (measured via the spot check approach)
Time frame: 5-7 days
Predictive value of each image-based parameter in the detection of postoperative complications
Time frame: 5-7 days
Effect of clinical deterioration detected with image-based, remote monitoring during hospital admission on long term patient outcomes (mortality, complications)
Time frame: 2 years
Invasion of privacy of image-based remote monitoring, experienced by patients and healthcare staff, presented on a likert scale (1 means no invasion of privacy at all and 5 serious invasion of privacy)
Time frame: 5-7 days
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 11 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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, Prof. dr. 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 and Clinical Deterioration, 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 4 inclusion and 5 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 11 Apr 2025. 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?
Percentage of signal coverage of remote, image-based monitoring in cardiac surgery patients on a general ward (time frame: 5-7 days). 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 11 Apr 2025.