Electrical Muscle Stimulation in the Development of Acquired Weakness in the Intensive Care Unit in Adult Patients With Severe Sepsis and Septic Shock at the Clinic Hospital of the Univerisity of Chile: Results of a Pilot Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 主要终点
- intensive care unit acquired weakness
研究概览
简要总结
The aim of this study is to compare the effect of EMS and conventional physical therapy on strength and muscle mass and development in adult patients with severe sepsis and septic shock.
详细描述
Septic patients are at high risk of developing intensive care unit acquired weakness (ICUAW). Electrical muscle stimulation (EMS) has become an alternative exercise for critical and non-cooperative patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects admitted to the ICU of the HCUCH in the period between November 2016 to August 2017 and January to June 2018
- •Diagnosis of severe sepsis or septic shock
- •More than 48 hours in VMI
- •With sedation and / or neuromuscular blockade
- •Autovalent prior to admission to the ICU
排除标准
- •Subjects from other hospitals / clinics or units of the hospital
- •Multiple trauma
- •Previous neuromuscular pathology
- •Pacemaker users
- •Pregnant women
- •Those who have refused to sign informed consent
研究组 & 干预措施
electrical muscle stimulation
conventional physical therapy according to the adaptation of the "Start to move" protocol of Gosselink et al. plus electrical muscle stimulation: The parameters used in biceps were: 35 Hz, 250 μs and in quadriceps were: 50 Hz, 400 μs. In both, biphasic wave was used, 45 minutes of total work, 5 seconds of contraction and 10 seconds of relaxation and the intensity was adjusted to present a visible contraction
干预措施: electrical muscle stimulation (Device)
electrical muscle stimulation
conventional physical therapy according to the adaptation of the "Start to move" protocol of Gosselink et al. plus electrical muscle stimulation: The parameters used in biceps were: 35 Hz, 250 μs and in quadriceps were: 50 Hz, 400 μs. In both, biphasic wave was used, 45 minutes of total work, 5 seconds of contraction and 10 seconds of relaxation and the intensity was adjusted to present a visible contraction
干预措施: conventional physical therapy (Procedure)
conventional physical therapy
conventional physical therapy according to the adaptation of the "Start to move" protocol of Gosselink et al
干预措施: conventional physical therapy (Procedure)
结局指标
主要结局
intensive care unit acquired weakness
时间窗: at awakening of the subject, an average of 8 days
Medical research council sum score: Bilateral testing of 6 muscle groups (shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, and ankle dorsiflexion). Ranges from 0 (total paralysis) to 60 (normal strength). Score under 48 points indicates intensive care unit acquired weakness
次要结局
- muscle mass(at ICU admission of the subjet, at 48 hours post admission and at awakening of the subject, an average of 8 days)
- days of ICU stay(at ICU discharge, an average of 18 days)
- mortality at 28 days(at 28 days post ICU admission)
- muscle strength(at awakening of the subject, an average of 8 days)
- maximum inspiratory pressure(at awakening of the subject, an average of 8 days)
- days of mechanical ventilation(an average of 11 days)
- Number of Participants with weaning failure(48 hours post extubation day)
- gait ability at hospital discharge(at hospital discharge, an averange of 3 months)
研究者
daniel arellano sepulveda
principal investigator
University of Chile