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Clinical Trials/NCT04076475
NCT04076475
Completed
Not Applicable

Effects of Neuromuscular Electrical Stimulation on Patients With Prolonged Mechanical Ventilation

Chang Gung University2 sites in 1 country8 target enrollmentFebruary 25, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prolonged Mechanical Ventilation
Sponsor
Chang Gung University
Enrollment
8
Locations
2
Primary Endpoint
tissue oxygenation
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
February 25, 2019
End Date
January 31, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Chen Yen-Huey

assist professor

Chang Gung University

Eligibility Criteria

Inclusion Criteria

  • 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)

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

tissue oxygenation

Time Frame: the 10th day of intervention

local muscle tissue oxygenation

oxygen consumption

Time Frame: the 10th day of intervention

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

muscle strength

Time Frame: 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)

Time Frame: the 10th day of intervention

pressure gauge

energy expenditure (calories)

Time Frame: the 10th day of intervention

the amount of energy expenditure which is measured by indirect calorimetry

pulmonary function (rapid shallow breathing index)

Time Frame: the 10th day of intervention

respiratory rate/tidal volume

Secondary Outcomes

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

Study Sites (2)

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