Evaluation of the Effect of Robot-assisted Early Mobilization on Critically Ill Patients, on the Mobilisation Behaviour and Experience of Mobilizing Professionals and Organisational Processes in an Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Evaluation of the effect of robot-assisted early mobilization on critically ill patients - Ventilation duration
研究概览
简要总结
Within the MobiStaR project the adaptation of procedures in an intensive care unit combined with the use of this robotic system will create the conditions to increase the mobilization rate of critically ill intensive care patients significantly, possibly thereby increasing the rehabilitation outcomes for these patients and developing a new standard of care for robot-assisted early mobilization.
The intervention study will assess the organizational feasibility of robot-assisted early mobilization (starting in the first 72 hours after admission to the ICU), the behavior and experience of the mobilizing professionals and the effects on patient outcomes in terms of ventilation time, muscle mass (sonographic examination) and physical activity (measured by established scores such as Functional Status Score for ICU (FSS-ICU) and Medical Research Council (MRC) classification).
详细描述
Early mobilization means the mobilization of critically ill patients in the early course after admission to the intensive care unit. The positive influence of early mobilization of critically ill patients on various aspects of patient outcomes has already been demonstrated. However, the implementation of early mobilization in clinical practice is difficult. Especially the high personnel effort is a barrier.
The Munich-based company Reactive Robotics (RR) is currently developing the world's first adaptive robotic assistance system VEMO©, which has CE approval for the planned indication and is to be used in the medium term for mobilizing intensive care patients.
Within the MobiStaR project, the adaptation of procedures in an intensive care unit combined with the use of this robotic system will create the conditions to significantly increase the mobilization rate of critically ill intensive care patients, possibly thereby increasing the rehabilitation results for these patients and developing a new standard of care for robot-assisted early mobilization. In this project, the robotic system will be used in anesthesiology intensive care units of the Ludwigs-Maximilians-University hospital.
Within this study, the effects of robot-assisted early mobilization will now be evaluated. This study comprises three study arms, in which (1) the feasibility and practicability of robot-assisted early mobilization, (2) the behavior and experience of the mobilizing professionals, and (3) the effect on patient outcomes will be evaluated.
The study is monocentric, prospective, interventional, does not include invasive procedures or blood sampling and has multiple data collection time points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 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
- •planned surgical intervention
- •postoperative intensive medical and therapeutic treatment
- •expected duration of ventilation > 48 hours
- •age ≥ 18 years
- •preoperative informed consent by the patients in the study
- •weight >45 kg and <135 kg
- •body height >1.50 m and <1.95 m
排除标准
- •patient refusal to participate in the study
- •unable to give consent
- •chronically bedridden before inclusion
- •clinical Frailty Scale ≥ 7
- •chronic ventilation (over 24h) before ICU admission
- •increased intracranial pressure / risk for increased intracranial pressure / recent cerebral hemorrhage
- •pregnancy
- •pre-existing neuromuscular disease resulting in chronic limitation of strength and efficiency
- •sternotomy / sternectomy during surgical procedure
结局指标
主要结局
Evaluation of the effect of robot-assisted early mobilization on critically ill patients - Ventilation duration
时间窗: 6 months
changes in ventilation duration (in hours) in comparison to a historical patient group
Evaluation of the effect of robot-assisted early mobilization on critically ill patients - sonographic examination thickness M. quad. femoris
时间窗: 6 months
muscle mass: Thickness M. quad. Femoris (in cm²) in comparison to a historical patient group
Evaluation of the effect of robot-assisted early mobilization on critically ill patients - sonographic examination thickness diaphragm inspiration
时间窗: 6 months
muscle mass: Thickness of diaphragm during inspiration (in cm) in comparison to a historical patient group
Evaluation of the effect of robot-assisted early mobilization on critically ill patients - sonographic examination- motility diaphragm breathing
时间窗: 6 months
muscle mass: motility of the diaphragm during breathing (in cm) in comparison to a historical patient group
Evaluation of the effect of robot-assisted early mobilization on critically ill patients - physical activity - FSS-ICU
时间窗: 6 months
physical activity measured using the score FSS-ICU (0 -35) in comparison to a historical patient group. A higher value means a better outcome.
Behavior and experience of the mobilizing professionals - qualitative interviews
时间窗: 6 months
subjectively experienced emotions, motivating and challenging factors - evaluated with a semi-structured interview guideline
Feasibility in organizational processes - eligible patients
时间窗: 6 months
Frequency of eligible patients (count per week: included patients in the study/ new eligible patients in the ICUs)
Evaluation of the effect of robot-assisted early mobilization on critically ill patients - sonographic examination Area of the M.rec.femoris
时间窗: 6 months
muscle mass (sonographic examination, in millimeters): Area of the M. rec. femoris in comparison to a historical patient group (in cm²)
Feasibility in organizational processes - mobilizations
时间窗: 6 months
frequency of robot-assisted mobilizations (per patient per day)
Evaluation of the effect of robot-assisted early mobilization on critically ill patients - physical activity
时间窗: 6 months
physical activity on upper and lower extremity measured using the Medical Research Council (MRC) score in comparison to a historical patient group. (0=absent muscle contraction, 1=visible muscle contraction, 2=movement when gravity is eliminated, 3=active movement against gravity, 4=active movement against resistance, 5=normal strength.)
Behavior and experience of the mobilizing professionals - qualitative observations
时间窗: 6 months
behavior and body posture during the mobilization - evaluated with a standardized observation sheet
Feasibility in organizational processes - adverse events
时间窗: 6 months
adverse events (count of patient-related, user-related or technology-related adverse events)
Evaluation of the effect of robot-assisted early mobilization on critically ill patients - sonographic examination thickness diaphragm exhalation
时间窗: 6 months
muscle mass: Thickness of diaphragm during exhalation (in cm) in comparison to a historical patient group
次要结局
- health related quality of life(6 months)
- cardiac output(6 months)
- respiration(6 months)
- Delir(6 months)
- Consciousness(6 months)
- Pain (VAS)(6 months)
- catecholamine demand(6 months)
- ICU Score - SOFA(6 months)
- Sedation level(6 months)
- Blood pressure(6 months)
- oxygen consumption(6 months)
- ICU Scores - SAPS II(6 months)
- heart rate(6 months)
- ICU Scores - APACHE II(6 months)
研究者
Dr. Uli Fischer
Head of executive department nursing science
Ludwig-Maximilians - University of Munich