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

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.

• 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.]