Vital Signs MonitoringNCT07486258
ADVANCE-FORSEE. ADVANCEd Video Monitoring FOR Early Signaling of Adverse Events and Optimal dischargE Planning.
An observational study of Vital Signs Monitoring and Complication, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
Trial summary
In this study cameras placed at the bedside will be evaluated for their ability to safely and accurately measure vital signs, such as heart rate and breathing, continuously after heart surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vital Signs Monitoring, Complication, Discharge Planning
- What is being tested?
- Camera-based monitoring technology
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2026to Dec 2028
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 for this study will be cardiac surgery patients admitted to the cardiothoracic ward of the Catharina hospital in Eindhoven. The research team will approach eligible patients who are scheduled to undergo cardiac surgery, in collaboration with the cardiothoracic surgeons. Due to the limited number of rooms equipped with the video-monitoring technology, patient placement on these rooms will be supported by the EuroSCORE II. When a room with the video-monitoring equipment is available, the EuroSCORE II ranking can be used as guidance by the day coordinator of the CTC to assign the room to an incoming patient with the highest estimated operative risk. Final room allocation will remain the responsibility of the CTC day coordinator.
Who may be able to join
- Patients admitted to the cardiothoracic ward after cardiac surgery
- Age ≥ 18
- Willing and able to sign informed consent form
Who cannot join
- Pregnancy
- Inability to provide written informed consent
- Mental disability
- Language barrier
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
Catharina Ziekenhuis Eindhoven
Eindhoven, North Brabant, 5623 EJ
About this study
In this study cameras placed at the bedside will be evaluated for their ability to safely and accurately measure vital signs, such as heart rate and breathing, continuously after heart surgery. Camera-based measurements will be compared with the usual checks that nurses perform several times a day using sensors on the skin or finger clip.
The goal is to see whether camera monitoring can help notice changes in a patient's condition earlier. Another aim of the study is to find out whether the camera monitoring can predict if a patient's health is improving or worsening.
Patients and healthcare staff will be asked by the investigators about their experience to learn whether this type of monitoring is acceptable in daily care.
Read the detailed description
Rationale: Over the past decades cardiothoracic surgery has advanced substantially resulting in reduced complication rates. However, when postoperative complications do occur they potentially can have a life-changing impact and sometimes even have death as a result. Therefore, timely detection of clinical deterioration is essential as early treatment may limit the severity of the complication and sometimes prevent their occurrence. The current method of vital signs monitoring, by nurses, usually 3 times a day, often leads to delayed detection of deterioration since early warning signs are missed and to standardized discharge protocols.
Objective: The primary objective of the ADVANCE FORSEE project is to evaluate the feasibility and acceptability of continuous video-based monitoring for early detection of postoperative deterioration as well as confirmation of uneventful recovery in cardiothoracic surgery patients. Secondary objectives are (1) to timely detect specific complications such as: atrial fibrillation, tamponade and acute coronary syndrome, (2) to assess the robustness of the video-based monitoring system, (3) to explore if additional physiological and other parameters can reliably be extracted and (4) to develop and evaluate a data management solution capable of efficiently handling large-scale video data.
Study design: Observational study, prospective for the data generation and retrospective for the data analysis. User-Centered Design with action research, allowing design and practice-oriented research to iteratively-reinforce each other.
Study population: 200-300 cardiac surgery patients.
Main study parameters/endpoints: The primary study endpoints are the performance of the deterioration detection and uneventful recovery algorithm assessed using a ROC-analysis. The secondary endpoints are (1) sensitivity, specificity and the time interval between algorithm-based deterioration detection and clinical confirmation by medical staff, (2) the accuracy of heart rate and respiratory rate for varying conditions, (3) the accuracy and feasibility of extracting additional parameters, (4) assessing the data management solution using RMSE as a function of bitrate across compression and storage models, (5) assessment of data loss, incorrect ROI detection and occlusion reported as percentages with 95% CI and compared to reference standards and (6) acceptability of the video-based monitoring system assessed by questionnaires, focus group and interviews.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participation to the study is not accompanied by clinical risk to the patient as the proposed technology is completely unobtrusive. Given the objective and hypothesis, the use of video-based monitoring in cardiac surgery patients has potential benefits to patients that outweigh the ethical constraints.
Furthermore, the technique has the potential to support Value-Based Health Care (VBHC) principles since it is expected to reduce the number of unexpected adverse events, better risk prediction, reduce hospital stay, reduce the workload of the nursing staff and hereby increase patient wellbeing by freeing up staff time for the patient.
- Conditions
- Vital Signs Monitoring, Complication, Discharge Planning
- Being tested
- Camera-based monitoring technology
- Keywords
- ADVANCE FORSEE, Vital Signs Monitoring, Video-based Monitoring, Complication Prediction, Discharge Readiness Planning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camera-based monitoring technologyDevice
Participants will be continuously monitored with multiple video cameras placed in their room on cardiothoracic surgery ward. The cameras record RGB, NIR and thermal video to allow extraction of vital signs and other non-regulated parameters. No physical contact or additional procedures are required and all usual clinical care continues as normal.
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary study endpoints are the performance of the deterioration detection and uneventful recovery algorithms and the acceptability of the video-based monitoring system among healthcare staff and patients.
Algorithm performance will be assessed using receiver operating characteristics (ROC) analysis expressed as the area under the curve (AUC) with corresponding 95% confidence intervals. As a comparison a ROC curve will be made based on the conventional EWS data. Sensitivity, specificity, positive and negative predictive value will be calculated accordingly.
Measured: From arrival on the cardiothoracic surgery ward until discharge (typically 2-7 days after surgery).
Secondary outcomes (6)
Sensitivity, specificity and time interval between algorithm-based detection and clinical confirmation.
Agreement between algorithm-based detection and clinical confirmation of postoperative complications. Sensitivity, specificity, and the time interval between the algorithm detection and confirmation by medical staff for events such as atrial fibrillation, acute coronary syndrome, tamponade, and other complications will be assessed.
Measured: From arrival on the cardiothoracic surgery ward until discharge (typically 2-7 days after surgery).
Accuracy and data coverage of video-derived heart rate and respiratory rate measurements under varying conditions.
Accuracy of video-derived heart rate and respiratory rate are compared with telemetry measurements under varying conditions. Data coverage is defined as the proportion of the monitoring period with usable video-based data.
Measured: From arrival on the cardiothoracic surgery ward until discharge (typically 2-7 days after surgery).
Accuracy and feasibility of extracting physiological and behavioral parameters such as oxygen saturation, eye movement, paleness and patient movement using the camera monitoring system.
Accuracy and feasibility of video-derived metrics including oxygen saturation, eye movement, paleness and patient movement using the camera monitoring system will be evaluated by comparing camera-based measurements with reference clinical measurements (telemetry-based monitoring) and clinical staff assessments. Measurement validity will be expressed using metrics such as sensitivity, specificity, correlation coefficients and agreement rates. Feasibility will be assessed based on the proportion of usable recordings and successful parameters extractions during postoperative monitoring.
Measured: From arrival on the cardiothoracic surgery ward until discharge (typically 2-7 days after surgery).
Performance of the data management solution
Performance is evaluated by calculating the RMSE of vital sign measurements using various data-management techniques.
Measured: From arrival on the cardiothoracic surgery ward until discharge (typically 2-7 days after surgery).
Quantitative assessment of acceptability of the video-based monitoring
Quantitative assessment of the acceptability of the video-based monitoring in terms of privacy, comfort, feeling of safety, ease of use and trust in the system will be assessed using structured questionnaires (Likert scale).
Measured: At postoperative day 5 or at hospital discharge whichever occurs first.
Qualitative assessment of acceptability of the video-based monitoring
Qualitative assessment of the acceptability of the video-based monitoring in terms of privacy, comfort, feeling of safety, ease of use and trust in the system using semi-structured interviews and focus groups.
Measured: At postoperative day 5 or at hospital discharge whichever occurs first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vital Signs MonitoringStudies 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
- 250 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, Lukas Dekker, Catharina Ziekenhuis Eindhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07486258
- Sponsor's protocol ID
- ADVANCE_FORSEE_1
- Status last verified
- Oct 2026
- First submitted
- 9 Mar 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The video data collected in this study are highly sensitive and contain personal information. To protect participant privacy, no individual participant data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADVANCE-FORSEE. ADVANCEd Video Monitoring FOR Early Signaling of Adverse Events and Optimal dischargE Planning.
- ClinicalTrials.gov ID
- NCT07486258
- Acronym / sponsor ID
- ADVANCE_FORSEE_1
- Conditions
- Vital Signs Monitoring, Complication, Discharge Planning
- Keywords
- ADVANCE FORSEE, Vital Signs Monitoring, Video-based Monitoring, Complication Prediction, Discharge Readiness Planning
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 20 Mar 2026 (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 cameras placed at the bedside will be evaluated for their ability to safely and accurately measure vital signs, such as heart rate and breathing, continuously after heart surgery. Camera-based measurements will be compared with the usual checks that nurses perform several times a day using sensors on the skin or finger clip.
The goal is to see whether camera monitoring can help notice changes in a patient's condition earlier. Another aim of the study is to find out whether the camera monitoring can predict if a patient's health is improving or worsening.
Patients and healthcare staff will be asked by the investigators about their experience to learn whether this type of monitoring is acceptable in daily care.
Detailed description
Rationale: Over the past decades cardiothoracic surgery has advanced substantially resulting in reduced complication rates. However, when postoperative complications do occur they potentially can have a life-changing impact and sometimes even have death as a result. Therefore, timely detection of clinical deterioration is essential as early treatment may limit the severity of the complication and sometimes prevent their occurrence. The current method of vital signs monitoring, by nurses, usually 3 times a day, often leads to delayed detection of deterioration since early warning signs are missed and to standardized discharge protocols.
Objective: The primary objective of the ADVANCE FORSEE project is to evaluate the feasibility and acceptability of continuous video-based monitoring for early detection of postoperative deterioration as well as confirmation of uneventful recovery in cardiothoracic surgery patients. Secondary objectives are (1) to timely detect specific complications such as: atrial fibrillation, tamponade and acute coronary syndrome, (2) to assess the robustness of the video-based monitoring system, (3) to explore if additional physiological and other parameters can reliably be extracted and (4) to develop and evaluate a data management solution capable of efficiently handling large-scale video data.
Study design: Observational study, prospective for the data generation and retrospective for the data analysis. User-Centered Design with action research, allowing design and practice-oriented research to iteratively-reinforce each other.
Study population: 200-300 cardiac surgery patients.
Main study parameters/endpoints: The primary study endpoints are the performance of the deterioration detection and uneventful recovery algorithm assessed using a ROC-analysis. The secondary endpoints are (1) sensitivity, specificity and the time interval between algorithm-based deterioration detection and clinical confirmation by medical staff, (2) the accuracy of heart rate and respiratory rate for varying conditions, (3) the accuracy and feasibility of extracting additional parameters, (4) assessing the data management solution using RMSE as a function of bitrate across compression and storage models, (5) assessment of data loss, incorrect ROI detection and occlusion reported as percentages with 95% CI and compared to reference standards and (6) acceptability of the video-based monitoring system assessed by questionnaires, focus group and interviews.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participation to the study is not accompanied by clinical risk to the patient as the proposed technology is completely unobtrusive. Given the objective and hypothesis, the use of video-based monitoring in cardiac surgery patients has potential benefits to patients that outweigh the ethical constraints.
Furthermore, the technique has the potential to support Value-Based Health Care (VBHC) principles since it is expected to reduce the number of unexpected adverse events, better risk prediction, reduce hospital stay, reduce the workload of the nursing staff and hereby increase patient wellbeing by freeing up staff time for the patient.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Week
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The intended population for this study will be cardiac surgery patients admitted to the cardiothoracic ward of the Catharina hospital in Eindhoven. The research team will approach eligible patients who are scheduled to undergo cardiac surgery, in collaboration with the cardiothoracic surgeons. Due to the limited number of rooms equipped with the video-monitoring technology, patient placement on these rooms will be supported by the EuroSCORE II. When a room with the video-monitoring equipment is available, the EuroSCORE II ranking can be used as guidance by the day coordinator of the CTC to assign the room to an incoming patient with the highest estimated operative risk. Final room allocation will remain the responsibility of the CTC day coordinator.
Key inclusion criteria (3 listed)
- Patients admitted to the cardiothoracic ward after cardiac surgery
- Age ≥ 18
- Willing and able to sign informed consent form
Key exclusion criteria (4 listed)
- Pregnancy
- 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 technologyParticipants will be continuously monitored with multiple video cameras placed in their room on cardiothoracic surgery ward. The cameras record RGB, NIR and thermal video to allow extraction of vital signs and other non-regulated parameters. No physical contact or additional procedures are required and all usual clinical care continues as normal. | Device | – |
Primary outcome
The primary study endpoints are the performance of the deterioration detection and uneventful recovery algorithms and the acceptability of the video-based monitoring system among healthcare staff and patients.
Time frame: From arrival on the cardiothoracic surgery ward until discharge (typically 2-7 days after surgery).
Algorithm performance will be assessed using receiver operating characteristics (ROC) analysis expressed as the area under the curve (AUC) with corresponding 95% confidence intervals. As a comparison a ROC curve will be made based on the conventional EWS data. Sensitivity, specificity, positive and negative predictive value will be calculated accordingly.
6 secondary outcomes
Sensitivity, specificity and time interval between algorithm-based detection and clinical confirmation.
Time frame: From arrival on the cardiothoracic surgery ward until discharge (typically 2-7 days after surgery).
Accuracy and data coverage of video-derived heart rate and respiratory rate measurements under varying conditions.
Time frame: From arrival on the cardiothoracic surgery ward until discharge (typically 2-7 days after surgery).
Accuracy and feasibility of extracting physiological and behavioral parameters such as oxygen saturation, eye movement, paleness and patient movement using the camera monitoring system.
Time frame: From arrival on the cardiothoracic surgery ward until discharge (typically 2-7 days after surgery).
Performance of the data management solution
Time frame: From arrival on the cardiothoracic surgery ward until discharge (typically 2-7 days after surgery).
Quantitative assessment of acceptability of the video-based monitoring
Time frame: At postoperative day 5 or at hospital discharge whichever occurs first.
Qualitative assessment of acceptability of the video-based monitoring
Time frame: At postoperative day 5 or at hospital discharge whichever occurs first.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No. The video data collected in this study are highly sensitive and contain personal information. To protect participant privacy, no individual participant data will be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Monitoring and Complication, 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: opening soon, as of the sponsor's last update on 22 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
The primary study endpoints are the performance of the deterioration detection and uneventful recovery algorithms and the acceptability of the video-based monitoring system among healthcare staff and patients. (time frame: From arrival on the cardiothoracic surgery ward until discharge (typically 2-7 days after surgery).). 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 22 Oct 2026.