Longitudinal Assessment of Delirium, Agitation/Sedation, Pain and Dyspnea in Patients Admitted to Respiratory Intensive Care Unit for Acute Respiratory Failure (NIVILIUM)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Incidence of delirium
研究概览
简要总结
Non-Invasive Mechanical Ventilation (NIV) has been increasingly used in the treatment of acute respiratory failure. Notwithstanding failure rates still remains high, ranging from 5% to 60%. The onset of delirium, agitation, pain and dyspnea may contribute to reduce the success rate of non invasive ventilation treatment. The aim of this study is to assess the incidence and impact of delirium, agitation, pain and dyspnea on clinical outcomes in a population of patient admitted to Respiratory Intensive Care Unit undergoing Non-Invasive Mechanical Ventilation for Acute Respiratory Failure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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 with acute respiratory failure admitted to the Respiratory Intensive Care Unit of the University Hospital of Modena undergoing non invasive mechanical ventilation
排除标准
- •age lower than 18
- •Glasgow Coma Scale lower than 10 within 24 hours from Respiratory Intensive Care Unit admission
- •need for immediate orotracheal intubation
- •pregnancy
- •previously established psychiatric disease or dementia
结局指标
主要结局
Incidence of delirium
时间窗: 7 days from Respiratory Intensive Care Unit admission
The onset of delirium will be assessed through the Confusion Assessment Method for Intensive Care Unit 7 scale, ranges 0-7, values \> 2 indicate the presence of delirium
Incidence of agitation
时间窗: 7 days from Respiratory Intensive Care Unit admission
The onset of delirium will be assessed through the Richmond Agitation Sedation Scale ranges +4 to -5, values \> 0 indicate the presence of agitation, values \< 0 indicate the presence of sedation
Incidence of dyspnea
时间窗: 7 days from Respiratory Intensive Care Unit admission
The onset of delirium will be assessed through the Borg scale, ranges 0-10, values \> 0 indicate the presence of dyspnea
Incidence of pain
时间窗: 7 days from Respiratory Intensive Care Unit admission
The onset of delirium will be assessed through the Behavioral Pain Scale, ranges 3-12, values \> 4 indicate the presence of pain
次要结局
- The impact of pain on Non Invasive Ventilation Success(30 days from Respiratory Intensive Care Unit admission)
- The impact of delirium on Non Invasive Ventilation Success(30 days from Respiratory Intensive Care Unit admission)
- The impact of dyspnea on Non Invasive Ventilation Success(30 days from Respiratory Intensive Care Unit admission)
- The impact of agitation on Non Invasive Ventilation Success(30 days from Respiratory Intensive Care Unit admission)
研究者
Alessandro Marchioni
Principal Investigator
University of Modena and Reggio Emilia