Sedation, ANalgesia and Delirium MANagement: a Study of Medical, Surgical, Trauma, and Neuro-intensive Care Patients and a COVID-19 Sub-study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,421
- 试验地点
- 1
- 主要终点
- Sedation practice
研究概览
简要总结
Patients with acute severe health problems often need to be admitted to specialised hospital wards called Intensive Care Units (ICUs) where they can receive emergency treatment such as mechanical ventilation to support their breathing function via a machine, and sedative medications to reduce pain and anxiety associated with the severity of their condition.
Although these interventions and treatments are often necessary to support patients' vital functions, they also carry the risk of important side effects.
Sedative drugs use in particular, has a significant impact on short- and long-term outcomes.
Despite international guidelines to help clinicians in the use of these drugs, there appears to be large variability in their use around the world such as use of different types of drugs, variable doses or rate of continuous infusions, etc.
However, even with this known variable practice across the world, there are no large-scale international studies looking at the use of sedative drugs, pain-relief medications and drugs to control agitation and restlessness in ICUs.
Therefore, the investigators propose a multinational study to better understand how different ICUs use these drugs and if they follow the guidance published by expert clinicians. The investigators will collect data in more than 100 ICUs across the world and include more than 2000 adult patients admitted to ICU and needing mechanical breathing.
There are no active interventions on patients that are part of this research study and data collection from patients medical records is retrospective. All patients included will receive the standard of care as per their local intensive care unit.
Also, in a 2-arm sub-study, the investigators will collect retrospective data from medical records of patients admitted to ICU before and during the COVID-19 pandemic to explore how sedation, analgesia and delirium practice has changed during this exceptional timeframe.
详细描述
Study design: Multicentre Retrospective Observational Cohort Study with two-arm COVID-19 sub-study (same design)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Sedation practice
时间窗: First 7 days of mechanical ventilation
Number of patient/days for each sedative and analgesic (propofol, benzodiazepines, opioids, etc.). Note: a full list of sedatives and analgesics is available in the eCRF.
Use of Pain, Analgesia and Delirium assessments
时间窗: First 7 days of mechanical ventilation
Number of patient/days when a Pain, Analgesia and Delirium assessment (any) has been used. Note: a list of PAD assessments is available in the eCRF.
次要结局
- Adherence to PADIS guidelines(First 7 days of mechanical ventilation)
- Sedation practice in different cohorts(First 7 days of mechanical ventilation)
- Delirium(First 7 days of mechanical ventilation)