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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'targetDuration': '1 Week', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-17', 'studyFirstSubmitDate': '2026-03-09', 'studyFirstSubmitQcDate': '2026-03-17', 'lastUpdatePostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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.', 'timeFrame': 'From arrival on the cardiothoracic surgery ward until discharge (typically 2-7 days after surgery).', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Sensitivity, specificity and time interval between algorithm-based detection and clinical confirmation.', 'timeFrame': 'From arrival on the cardiothoracic surgery ward until discharge (typically 2-7 days after surgery).', 'description': '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.'}, {'measure': 'Accuracy and data coverage of video-derived heart rate and respiratory rate measurements under varying conditions.', 'timeFrame': 'From arrival on the cardiothoracic surgery ward until discharge (typically 2-7 days after surgery).', 'description': '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.'}, {'measure': 'Accuracy and feasibility of extracting physiological and behavioral parameters such as oxygen saturation, eye movement, paleness and patient movement using the camera monitoring system.', 'timeFrame': 'From arrival on the cardiothoracic surgery ward until discharge (typically 2-7 days after surgery).', 'description': '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.'}, {'measure': 'Performance of the data management solution', 'timeFrame': 'From arrival on the cardiothoracic surgery ward until discharge (typically 2-7 days after surgery).', 'description': 'Performance is evaluated by calculating the RMSE of vital sign measurements using various data-management techniques.'}, {'measure': 'Quantitative assessment of acceptability of the video-based monitoring', 'timeFrame': 'At postoperative day 5 or at hospital discharge whichever occurs first.', 'description': '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).'}, {'measure': 'Qualitative assessment of acceptability of the video-based monitoring', 'timeFrame': 'At postoperative day 5 or at hospital discharge whichever occurs first.', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ADVANCE FORSEE', 'Vital Signs Monitoring', 'Video-based Monitoring', 'Complication Prediction', 'Discharge Readiness Planning'], 'conditions': ['Vital Signs Monitoring', 'Complication', 'Discharge Planning']}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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.\n\nPatients and healthcare staff will be asked by the investigators about their experience to learn whether this type of monitoring is acceptable in daily care.", 'detailedDescription': '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.\n\nObjective: 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.\n\nStudy 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.\n\nStudy population: 200-300 cardiac surgery patients.\n\nMain 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.\n\nNature 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.\n\nFurthermore, 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients admitted to the cardiothoracic ward after cardiac surgery\n* Age ≥ 18\n* Willing and able to sign informed consent form\n\nExclusion Criteria:\n\n* Pregnancy\n* Inability to provide written informed consent\n* Mental disability\n* Language barrier'}, 'identificationModule': {'nctId': 'NCT07486258', 'briefTitle': 'ADVANCE-FORSEE. ADVANCEd Video Monitoring FOR Early Signaling of Adverse Events and Optimal dischargE Planning.', 'organization': {'class': 'OTHER', 'fullName': 'Catharina Ziekenhuis Eindhoven'}, 'officialTitle': 'ADVANCE-FORSEE. ADVANCEd Video Monitoring FOR Early Signaling of Adverse Events and Optimal dischargE Planning.', 'orgStudyIdInfo': {'id': 'ADVANCE_FORSEE_1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Camera-based monitoring technology', 'type': 'DEVICE', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '5623 EJ', 'city': 'Eindhoven', 'state': 'North Brabant', 'country': 'Netherlands', 'facility': 'Catharina Ziekenhuis Eindhoven', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Catharina Ziekenhuis Eindhoven', 'class': 'OTHER'}, 'collaborators': [{'name': 'ZonMw: The Netherlands Organisation for Health Research and Development', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'prof. dr.', 'investigatorFullName': 'Lukas Dekker', 'investigatorAffiliation': 'Catharina Ziekenhuis Eindhoven'}}}}