Early Rehabilitation of Intensive Care Unit Patients - a Multinational Prospective Observational Study on Dosage and Outcome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 6,000
- 试验地点
- 1
- 主要终点
- Physical function at ICU discharge
研究概览
简要总结
Rehabilitation already begins in the intensive care unit (ICU) to maintain or restore the functional capacity of ICU patients and to counteract the long-term effects of intensive care treatment. Mobilisation is an important component.
The aim of this multinational observational study is to record and evaluate the different mobilisation practices for ICU patients worldwide. The investigators want to find out which forms of mobilisation in intensive care patients achieve the best results in terms of physical function, functional status and quality of life.
The goal is to recruit over 6,000 patients internationally. No interventions will be carried out, only routine clinical data will be documented and standardised and already established physical tests and questionnaires will be used.
详细描述
Intensive care treatment can have long-term effects on patients. Around 40% of intensive care unit (ICU) patients develop an Intensive Care Unit Acquired Weakness (ICUAW), which leads to functional limitations and an impairment of independence, participation in everyday life, quality of life and ability to work. Recent studies have shown that early mobilisation has a positive effect on the course of the disease, including improved physical function and independence, shorter ventilation times, and shorter ICU and hospital stays. However, there is currently no standardised approach to mobilisation and the dosage required to achieve the best health outcomes in ICU patients is unknown. There is also a lack of data on patients who were functionally dependent before hospital admission and on patients who were not on invasive mechanical ventilation.
The main objectives of the observational study are:
- Assessment of the variety of different mobilisation practices worldwide.
- The analysis of the association of mobilisation dosage on patient outcomes.
- The evaluation of the association of the prehospital functional status or invasive mechanical ventilation on patient outcomes.
The investigators aim to recruit over 6,000 patients internationally from a minimum of 200 intensive care units. The total duration of the study is 21 months, with participation per patients being 90 days. Routine clinical data and mobilisation data from ICU will be documented, and standardised functional tests and questionnaires will be conducted.
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
- •Adults (≥ 18 years old) within 48 hours of ICU admission
- •Expected to stay > 24 hours in the ICU
排除标准
- •Patients who receive end-of-life care at the time of screening
- •Patients whose treatment plans are still under discussion and/or not all team members are committed to full active treatment
- •Patients whose functional status is unlikely to be obtainable
- •Patients with language barriers
研究组 & 干预措施
Independent
Patients who have been functionally independent before ICU admission
Dependent
Patients who have been functionally dependent before ICU admissoin
结局指标
主要结局
Physical function at ICU discharge
时间窗: ICU discharge (up to Day 28)
Physical function measured with the Functional Status Score for the Intensive Care Unit (FSS-ICU). The total score ranges from 0 to 35, with higher scores indicating better physical function.
次要结局
- 90-day mortality(Day 90)
- Hospital LOS(ICU admission until hospital discharge)
- ICU mortality(ICU admission until ICU discharge (up to Day 28))
- Hospital mortality(ICU admission until hospital discharge)
- Highest level of mobility at ICU discharge and 90 days(ICU discharge (up to Day 28) and Day 90)
- Physical function at 90 days(Day 90)
- Frailty/ Functional status at ICU discharge and 90 days(ICU discharge (up to Day 28) and Day 90)
- ICU LOS(ICU admission until ICU discharge (up to Day 28))
- Disability at 90 days(Day 90)
- Activities of Daily Living (ADLs) at ICU discharge and 90 days(ICU discharge (up to Day 28) and Day 90)
研究者
Stefan Schaller
Professor of Anaesthesia and Anaesthesiological Intensive Care Medicine
Medical University of Vienna