Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 1:32 AM
Study NCT ID:
NCT07486258
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-20
First Post:
2026-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ADVANCE-FORSEE. ADVANCEd Video Monitoring FOR Early Signaling of Adverse Events and Optimal dischargE Planning.
Sponsor:
Catharina Ziekenhuis Eindhoven
Organization:
Study Overview
Official Title:
ADVANCE-FORSEE. ADVANCEd Video Monitoring FOR Early Signaling of Adverse Events and Optimal dischargE Planning.
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: