ADVANCE-FORSEE. ADVANCEd Video Monitoring FOR Early Signaling of Adverse Events and Optimal dischargE Planning.

NCT07486258 | Not Yet Recruiting

• 1 other identifier: ADVANCE_FORSEE_1
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Vital Signs Monitoring; Complication; Discharge Planning

Keywords

ADVANCE FORSEE; Vital Signs Monitoring; Video-based Monitoring; Complication Prediction; Discharge Readiness Planning

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  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.

  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.

  From arrival on the cardiothoracic surgery ward until discharge (typically 2-7 days after surgery).

• Performance of the data management solution

  From arrival on the cardiothoracic surgery ward until discharge (typically 2-7 days after surgery).

• Quantitative assessment of acceptability of the video-based monitoring

  At postoperative day 5 or at hospital discharge whichever occurs first.

Interventions

Camera-based monitoring technology DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Patients admitted to the cardiothoracic ward after cardiac surgery
• Age ≥ 18
• Willing and able to sign informed consent form

You may not qualify if:

• Pregnancy
• Inability to provide written informed consent
• Mental disability
• Language barrier

Sponsors & Collaborators

• Catharina Ziekenhuis Eindhoven: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

Catharina Ziekenhuis Eindhoven

Eindhoven, North Brabant, 5623 EJ, Netherlands

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr.

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 20, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)