Early Mobilisation in Intensive Therapy
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- The primary outcome is to measure the functional ability of the patients
研究概览
简要总结
Abstract Many patients experience serious reduced functional ability after a critical illness and hospitalization in an Intensive Care Unit. The cause of the reduced functional ability is the combination of critical illness and immobilization following treatment with a ventilator. The functional ability of patients can be affected up till a year after the discharge, and may shows a decrease in ability to walk and in problems with focusing.
Studies show that it is safe and possible to mobilize the patients with for instance bed bikes, sitting up and standing up, even during ventilator therapy. The effect is shown as lesser days with delirium, on a ventilator therapy or hospitalization. No study has shown how early and at which intensity a patient can be mobilized. Our hypothesis is that an early systematic mobilization improves functional ability of the critically ill patient, mentally, physically and their life expectancy. The purpose of this study is to evaluate a mobilization protocol applied at critically ill patients, including a contribute related to knowledge of how soon and how intense patients ventilated for more than 48 hours can endure mobilization. To evaluate the connections between functional ability and life expectancy for critically ill patients are compared to a population matching in age.
This intervention project has a multicenter design with pre- and post research related to effect in early systematic mobilization of critically ill patients. 200 patients are included in the project.
Data are collected at tests showing the functional ability of patients in different ways. The tests are made at the discharge from the Intensive Care Unit and 5 days after at their wards and again at 3 and 12 month from discharge when the patients have returned to their home. The project started in February 2011 and is expected to end in May 2013, findings is expected in November 2013.
详细描述
Background Many patients experience serious reduced functional ability in form of physical and mental problems (1) after a critical illness and prolonged stay at an Intensive Care Unit. The critical illness entails the need for sedation and mechanical ventilation leading to immobilization as a consequence.
The combination of critical illness and immobilization leads to an increased risk of further muscle deterioration and it is assumed that this condition deteriorates the inflammatory response (2, 3, 4, 5).
Immobilization is an important contributory cause of reduced functional ability independent of critical illness. The deterioration is noticed up till a year after the discharge from hospital (1, 6) and physically it is shown in a reduced ability to walk (1, 6, 7), and mentally as delirium, associated with increased mortality and an extended period of hospitalisation. The mentally effects show a deterioration 1 year after the discharge from hospital.
The symptoms appear as difficulty concentrating and evaluated poor health (1, 6, 7).
Mobilization has a positive effect on the functional ability of patients, physically and mentally (8, 9, 10, 11, 12) even during mobilizing in connection with wake up calls of sedated patients 10). The patients experience less fear and dependency, they are in control to a greater extent (10) and also a significant increase in the ability to walk is shown (13). The mobilized patients have fewer days of delirium, mechanical ventilation and lesser days at Intensive Care Units (10, 12). It is possible to mobilize critically ill patients in bed by means of passive and active exercises. The exercises consist of getting out of bed, sitting on the edge of the bed, moving from bed to chair, standing on the floor, standing up, sitting in a chair and walking (10,13,14,15,16), but it is recommended that there is a close interdisciplinary collaboration between nurse and physiotherapist (17, 18, 19, 20, 21, 22).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 who will be included:
- •Patients hospitalized in Unit 4141, at Rigshospitalet or ICU at Slagelse, who have been intubated for more than 48 hours,
- •age ≥ 18, and
- •after positive confirmation from relatives that the patient before the hospitalization was able to read and understand instructions.
- •Patients who will be excluded:
- •Patients with a terminal illness,
- •users of wheelchairs,
- •patients with a known cognitive disturbance,
- •open thorax,
- •patient who is not allowed to mobilizing during their stay in ICU, and finally
- •patients living outside Sjaelland, Lolland and Falster.
排除标准
- 未提供
结局指标
主要结局
The primary outcome is to measure the functional ability of the patients
时间窗: 3 years
The primary outcome is to measure the functional ability of the patients related to systematic mobilization. The patients stamina, balance, strength, experience and sense of control and emotional energy in relation to social contact is also measured. Correlation between functional ability and life expectancy is measured through their own judgment in relation to their physical level of activity, before hospitalisation and after discharge.
次要结局
- Is to measure the effect of mobilization related to time in hospital(2. year)
研究者
Anne Skafte
Nurse
Region Zealand