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Completed

NCT Number: NCT04076475

Neuromuscular Electrical Stimulation in Patients With Prolonged Mechanical Ventilation

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept of Respiratory therapy, Chang Gung University, Taoyuan, Taiwan

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About this study

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:

  • to examine the acute effects of NMES on the microcirculation, physiologic response and metabolic demand in patients with PMV.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • pregnancy
  • severe edema (deep indentation when pressing a finger into the skin, requiring >30 s to rebound

Treatment and study plan

Neuromuscular Electrical Stimulation

Device

Participants will receive muscular electrical stimulation on quadriceps muscle and abdominal muscles for 30 min/day for 10 days

Primary outcomes

  1. tissue oxygenation

    Time frame: the 1st day of intervention

    local muscle tissue oxygenation

  2. tissue oxygenation

    Time frame: the 10th day of intervention

    local muscle tissue oxygenation

  3. muscle strength

    Time frame: the 1st day of intervention

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

  4. 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).

  5. pulmonary function (maximal inspiratory pressure)

    Time frame: the 1st day of intervention

    pressure gauge

  6. pulmonary function (maximal inspiratory pressure)

    Time frame: the 10th day of intervention

    pressure gauge

  7. oxygen consumption

    Time frame: the 1st day of intervention

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

  8. oxygen consumption

    Time frame: the 10th day of intervention

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

  9. energy expenditure (calories)

    Time frame: the 1st day of intervention

    the amount of energy expenditure which is measured by indirect calorimetry

  10. energy expenditure (calories)

    Time frame: the 10th day of intervention

    the amount of energy expenditure which is measured by indirect calorimetry

  11. pulmonary function (rapid shallow breathing index)

    Time frame: the 1st day of intervention

    respiratory rate/tidal volume

  12. pulmonary function (rapid shallow breathing index)

    Time frame: the 10th day of intervention

    respiratory rate/tidal volume

Secondary outcomes

  1. weaning rate

    Time frame: through study completion, an maximal 42 days

    ventilator weaning results (weaning successful/failure)

  2. length of stay in respiratory care center

    Time frame: through study completion, an maximal 42 days

    the total days of stay in respiratory care center

Sponsors and collaborators

Lead sponsor

Chang Gung University

Other

Collaborators

  • Chang Gung Memorial Hospital

Registry information

Official study title

Effects of Neuromuscular Electrical Stimulation on Patients With Prolonged Mechanical Ventilation

Acronym: NMES

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 3, 2019
Registry last updated
Jul 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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