Randomised Pilot Study on Device-assisted Mobilisation With a Sit/Stand Stabiliser of Critically Ill Patients With Ventilatory Support
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Level of mobilisation (IMS)
研究概览
简要总结
This Pilot study will hypothesize that patients with organ insufficiency and breathing assistance in our post-anaesthesia care unit (PACU) and ICU will be mobilized more often to an ICU mobility scale (IMS) ≥ 4 (i.e. standing) using the Liana® mobilizer. Therefore a randomized controlled pilot study will be conducted. The aim is to achieve an important physical function mile stone more often using this device.
Secondary hypotheses are:
- The intervention will relieve the burden of the health care staff in the unit
- The intervention will positively influence the functional outcome of critically ill patients
- The intervention is perceived as positive by the patients
详细描述
Patients who have been treated in the ICU for a prolonged period of time often have a high degree of immobility. In this context, a state of generalized weakness associated with muscle atrophy (ICUAW) develops in approximately 40% of ICU patients. The severity of generalized weakness may be individual in each patient. It is certain that especially elderly patients and patients with prolonged immobilization have an increased incidence of ICUAW. Symptoms can be highly variable depending on the severity of the course. Some patients report weakness of the extremities to paresis and weakness of the respiratory muscles. Weakness of the respiratory musculature can lead to a prolonged weaning process of mechanical ventilation, prolonging the stay in the ICU. Functional impairments due to ICUAW may also persist many years after the ICU stay. If ICUAW is diagnosed promptly, outcome can be improved by targeted early mobilization. Early mobilization is defined as mobilization in the first 72 h from ICU admission. However, there are numerous barriers to the implementation of early mobilization in critically ill patients, so this remains a major challenge.
Various studies have shown that patients can benefit from a high level of mobilization. For example, Scheffenbichler et al. showed that a high dose of mobilization was associated with increased independence of patients after discharge. The level of mobilization showed positive effects not only in this study, but also in Paton and colleagues. They were able to show that achieving a higher level of mobility (according to the Intensive Care Mobility Scale) was associated with improved outcome at six months. They found that achieving a higher level of mobilization positively affected the health status of patients, whereas increasing the number of mobilizations did not.
With device-assisted mobilization, patients could be mobilized to standing position early and more frequently. The aim of this pilot study is to test whether mobilization of critically ill patients with ventilatory support using device-assisted mobilization leads to increased mobilization to standing (IMS 4) or beyond.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Intensive care patient with ventilatory support and an expected intensive care stay of at least another 48 h
- •Age ≥ 18 years
- •Current length of intensive care stay < 48 h
排除标准
- •Moribund and critically ill
- •Suspected 6-month mortality > 75%.
- •Increased intracranial pressure
- •Critically ill after cardiopulmonary resuscitation
- •Critically ill with primary neuromuscular disease or motor neuron disease
- •One or more amputated extremities
- •Patients, within 2h after surgery
- •Unstable fractures
- •Severe traumatic brain injury (e.g., brain and skull injuries)
- •Circulatory instability with norepinephrine > 0.3 µg/kg/min
- •Patients for whom there is an indication for deep sedation (RASS -5)
- •Language barrier
- •Fitting of legs into leg trays is not possible due to e.g. patient weight
研究组 & 干预措施
Intervention Group
Mobilization incl. support by the Liana. In the intervention group, Liana is used to train trunk stability in a sitting position. If this is successful, the patient is trained to stand. Mobilization to higher levels is performed according to clinical standards.
干预措施: Device-assisted mobilisation with the sit/stand stabilizer Liana (Device)
Control Group
Standard of Care without the use of the Liana. In the control group the therapy is carried out according to the ward standard without using the Liana.
结局指标
主要结局
Level of mobilisation (IMS)
时间窗: 28 Days
Mean level of mobilisation measured with the Intensive Car Unit Mobility Scale (IMS) till ICU discharge (or Day 28); IMS ranges from 0 (no mobilization) to 10 (independent walking)
次要结局
- Handgrip strength(28 Days)
- MRC Sum Score(28 Days)
- Duration of MV(180 Days)
- CPAx Score(28 Days)
- Trunk Control Test(28 Days)
- Staff satisfaction with VRS(28 Days)
- Hospital LOS(180 Days)
- Diaphragma function(28 Days)
- Patient satisfaction with VRS(28 Days)
- Time in rehabilitation and hospital(180 Days)
- (I)ADL(180 Days)
- Frequency of IMS ≥ 4(28 Days)
- Staff binding time(28 Days)
- ICU LOS(180 Days)
- Quality of life(180 Days)
- Disability(180 Days)
- Physical Function(180 Days)
研究者
Stefan J Schaller
Deputy Clinical Director
Charite University, Berlin, Germany