Study of Feasibility and Safety of Functional Electrical Stimulation (FES) Cycling in Intensive Care Unit Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Tolerance
研究概览
简要总结
Intensive care unit acquired muscle weakness (ICUAW), is a common disease which influence rehabilitation, extend mechanical ventilation and length of stay in intensive care unit, and affect quality of life at hospital discharge.
To prevent ICUAW, different strategies of early mobilization are recommended. But all cannot be applied in all ICU patients. Some of them benefit from heavy therapies like circulatory assistance or renal replacement therapy for example, that limit mobilization.
Cycloergometer is a tool that allows continuous passive mobilization in bedridden and even unconscious patients.
Neuromuscular electrical stimulation (NMES) is an alternative that helps preserve muscle mass and limit muscle atrophy.
Early bedside cycle exercise coupled with NMES is an interesting new approach where application of an electrical stimulation along specific motor nerves on each lower limb, generates muscles contractions and pedaling on cycloergometer.
The aim of this study is to evaluate safety and feasibility of this coupled technique called Functional Electrical Stimulation (FES) Cycling, in ICU patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Age ≥ 18 years
- •Deeply sedated (Riker 1-2) patients, admitted in intensive care unit B of ST-Etienne hospital
- •Without curare since 12 hours
- •Normothermic or with a controlled fever (central temperature between 36 and 38°C)
- •Without haemodynamic instability (mean arterial pressure > 65mmHg and < 120mmHg, systolic arterial pressure > 90mmHg and < 200mmHg, Norepinephrine < 4mg/h)
- •Without respiratory instability (respiratory rate < 35/min, pulse oxymetry > 90%, inspired oxygen fraction < 60%, PaO2/FiO2 ratio > 250, Peep < 10cmH2O, with invasive mechanical ventilation)
- •Without neurological instability (diastolic velocities in mean cerebral artery > 30cm/s, mean velocities > 50cm/s, pulsatility index < 1.2, intracranial pressure < 20mmhg, brain tissue oxygenation tension > 15mmHg)
- •Patient whose family has given informed and written consent to the patient's participation in the study
排除标准
- •Pregnant woman,
- •Patients with peripheral nerve damage prior to or at the time of measurement
- •Curarized patients (non-efficacy of neurostimulation)
- •Presence of a catheter in the stimulation zone (femoral artery or vein)
- •Patients with lower limb, pelvic or spine fracture
- •Patients with continuous renal replacement therapy
- •Patients with circulatory assistance
- •Patients with wounds in electrodes placement area
- •Morbidly obesity with Ideal Body Weight > 40kg/m2
- •Patients with pacemaker
- •Lower limb deep vein thrombosis without treatment
结局指标
主要结局
Tolerance
时间窗: During the FES Cycling session (day 1)
Number of FES Cycling sessions that must be stopped because of the presence of at least 1 following criteria (these criteria are qualitative (presence or absence) and therefore do not add up): * Mean arterial pressure \<65mmHg or\> 120mmHg, * Systolic blood pressure \<90 mmHg or\> 200 mmHg, * Heart rate \<50 or\> 130 / min * Occurrence of atrial or ventricular arrhythmia * Respiratory rate \> 35 / min, * Pulse oxygen saturation \<90% * Intracranial pressure \> 20mmHg. * Mean mean arterial velocity measured by transcranial Doppler \<30 cm / s
次要结局
- FES Cycling technical feasibility(After the FES Cycling session (day 1))
- Haemodynamic tolerance Heart rate(During the FES Cycling session (day 1))
- Respiratory rate(During the FES Cycling session (day 1))
- Intracranial pression(During the FES Cycling session (day 1))
- Pulsatility index(During the FES Cycling session (day 1))
- Systolic blood pressure(During the FES Cycling session (day 1))
- Amine dosage(During the FES Cycling session (day 1))
- Failure FES Cycling session(After the FES Cycling session (day 1))
- Fick equation(During the FES Cycling session (day 1))
- Arterial lactates(During the FES Cycling session (day 1))
- Venous oxygen(During the FES Cycling session (day 1))
- Cardiac output measured(During the FES Cycling session (day 1))
- Respiratory tolerance Oxygen saturation(During the FES Cycling session (day 1))
- Diastolic cerebral artery(During the FES Cycling session (day 1))
- FES cycling installation(After the FES Cycling session (day 1))
- Duration of FES Cycling session(After the FES Cycling session (day 1))
- Respiratory tolerance(During the FES Cycling session (day 1))
- Cerebral perfusion pressure(During the FES Cycling session (day 1))
- Cerebral tissue oxygen pressure(During the FES Cycling session (day 1))