跳至主要内容
临床试验/NCT04076475
NCT04076475已完成不适用

Effects of Neuromuscular Electrical Stimulation on Patients With Prolonged Mechanical Ventilation

Chang Gung University4 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2019年2月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
4
主要终点
tissue oxygenation

研究概览

简要总结

Prolonged mechanical ventilation has been defined as the need for >21 days. The muscle weakness occurred most commonly in patients with PMV and resulted in increasing time to wean from mechanical ventilation, and longer stay in hospital.

Neuromuscular electrical stimulation (NMES) involves applying a stimuli to skeletal muscle, to trigger muscle contraction, and it can be used for the recovery of muscle mass and muscle strength following prolonged immobilization. NMES also improve microcirculation and systemic circulation in patients with cardiopulmonary diseases.

The purposes of this study:

  1. to examine the acute effects of NMES on the microcirculation, physiologic response and metabolic demand in patients with PMV.
  2. to investigate the training effects of NMES on microcirculation, muscle strength and weaning outcomes in patients with PMV.

METHODS: Subjects with PMV are recruited and are randomly assigned into NMES (n=20) or control group (n=20).The NMES group receive daily NMES for 30 min/session for 10 days. The assessment of muscle strength and weaning profile were performed before and after intervention. During the first and the last NMES session, the status of microcirculation and local muscle tissue oxygenation will be measured by NIRS, and the metabolic status will be measured by IC. The ventilator weaning rate and length of stay in RCC will be recorded.

详细描述

Scientific and technologic advances in medicine have resulted in the ability of the medical team to prolong life. One consequence of life-extending advancements in technology is the increasing numbers of patients requiring prolonged mechanical ventilation (PMV). Prolonged mechanical ventilation has been defined as the need for 21 days, of consecutive mechanical ventilation for six hours/day. The interaction of underlying diseases and prolong bedridden result in various complication in patients with PMV. Known complications can include: muscle weakness, atelectasis, and deconditioning. The muscle weakness occurred most commonly in patients with PMV and resulted in increasing time to wean successfully from mechanical ventilation, and longer stay in hospital. Exercise is effective in improving muscle strength and physical function in patients with heart failure and chronic obstructive pulmonary disease (COPD. However, patients with PMV may be too fragile to perform excise. Neuromuscular electrical stimulation (NMES) involves applying a series of stimuli to skeletal muscle, primarily to trigger muscle contraction, and it can be used for the recovery of muscle mass and muscle strength following prolonged immobilization. NMES also improve microcirculation and systemic circulation in patients with cardiopulmonary diseases. In addition, the application of NMES increases oxygen consumption of whole body and elicits physiologic effects that are similar to aerobic exercise. However, the effects of NMES on the PMV population remain unclear. Near-infrared spectroscopy (NIRS) is a recently developed noninvasive method of measuring tissue oxygenation, blood flow, and local tissue metabolism. NIRS combined with a vascular occlusion test is proposed as a tool to assess the microvascular response. Indirect calorimetry (IC) uses the method of breath-bybreath monitoring by pneumotachography to measure oxygen consumption (VO2) and carbon dioxide production (VCO2).

The purposes of this study:

  1. to examine the acute effects of NMES on the microcirculation, physiologic response and metabolic demand in patients with PMV.
  2. to investigate the training effects of NMES on microcirculation, muscle strength and weaning outcomes in patients with PMV. METHODS: Subjects who have been on ventilator for>= 21 days are recruited form respiratory care center (RCC) and are randomly assigned into NMES (n=20) or control group (n=20).The NMES group receive daily NMES for 30 min/session for 10 days. The assessment of muscle strength and weaning profile were performed before and after intervention. During the first and the last NMES session, the status of microcirculation and local muscle tissue oxygenation will be measured by NIRS, and the metabolic status will be measured by IC. The mechanical ventilator weaning outcomes and length of stay in RCC will be recorded. The results of this study help us to confirm whether the application of NMES is beneficial in the improvement of muscle strength in patients with PMV, and to furtherly understand the mechanisms. The results may provide an alternative options for clinicians functional and hospitalization outcomes in patients with PMV.

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
Single (Participant)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age ≧ 20 years;
  • MV for > 6 h/day for > 21 days; and
  • medical stability, absence of signs and symptoms of infection, and hemodynamic stability).
  • hemodynamic stable without or with a low dose of vasopressor ((Dopamine or Dobutamine <5μg/kg/min)

排除标准

  • acute lung or systemic infection,
  • ongoing neuromuscular disease (e.g., myasthenia gravis, Guillain-Barre disease)
  • bone contracture or skin lesion
  • obesity [body mass index (BMI) >35 kg/m2].
  • disease at end-stage with expecting survival <=6month
  • severe edema (deep indentation when pressing a finger into the skin, requiring >30 s to rebound

结局指标

主要结局

tissue oxygenation

时间窗: the 10th day of intervention

local muscle tissue oxygenation

oxygen consumption

时间窗: the 10th day of intervention

the amount of oxygen that body consume, is measured by indirect calorimetry

muscle strength

时间窗: the 10th day of intervention

Medical research council score. The score ranges from a 0 points (zero strength) to 5 points (good).

pulmonary function (maximal inspiratory pressure)

时间窗: the 10th day of intervention

pressure gauge

energy expenditure (calories)

时间窗: the 10th day of intervention

the amount of energy expenditure which is measured by indirect calorimetry

pulmonary function (rapid shallow breathing index)

时间窗: the 10th day of intervention

respiratory rate/tidal volume

次要结局

  • weaning rate(through study completion, an maximal 42 days)
  • length of stay in respiratory care center(through study completion, an maximal 42 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chen Yen-Huey

assist professor

Chang Gung University

研究点 (4)

Loading locations...

相似试验