ADVANCE-FORSEE. ADVANCEd Video Monitoring FOR Early Signaling of Adverse Events and Optimal dischargE Planning.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted to the cardiothoracic ward after cardiac surgery
- •Willing and able to sign informed consent form
排除标准
- •Pregnancy
- •Inability to provide written informed consent
- •Mental disability
- •Language barrier
结局指标
主要结局
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.
时间窗: 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.
次要结局
- 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.)
- Qualitative assessment of acceptability of the video-based monitoring(At postoperative day 5 or at hospital discharge whichever occurs first.)
研究者
Lukas Dekker
prof. dr.
Catharina Ziekenhuis Eindhoven