TIRESIA Project - Severe Acquired Brain Injuries: Prognostic Factors and Quality of Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,500
- 试验地点
- 27
- 主要终点
- Total feeeding by os
研究概览
简要总结
The main purpose of this project is to identify the medium-term prognostic factors for patients with Severe Acquired Brain Injuries and evaluate their impact.
The secondary aim is to create a system of continuous assessment of the quality of care for each rehabilitation unit.
详细描述
For each unit involved, it will be collected these data :
- Structural and organizational data of the Rehabilitation Units for Severe Acquired Brain Injuries;
- Detailed information on patients upon entering Rehabilitation Units for Severe Acquired Brain Injuries;
- Detailed information on patients, re-evaluated 4 months after the acute event
Statistical models will be implemented, in order to identify prognostic factors that could predict the probability to observe three events, which represent objectives of the rehabilitation process: decannulation, trunk control and total feeding by os. These events should be evaluated four months after the acute episode.
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 Serious Acquired Brain Injuries
- •admission to rehabilitation units
排除标准
- •patients admitted more than 14 weeks after the acute event
结局指标
主要结局
Total feeeding by os
时间窗: july 2021 - june 2025
Oral feeding with sufficient caloric intake
Tracheostomy tube
时间窗: july 2021 - june 2025
Removal of the tracheostomy tube, which is considered successful if the patient is not to be re-cannulated within 7 days
Trunk control
时间窗: july 2021 - june 2025
Achievement of trunk control, for which the patient must be able to maintain the sitting position for at least 60 seconds, on a rigid surface, with the lower limbs in support, but without support from the upper limbs and without rear support of the trunk
次要结局
未报告次要终点