Neuromuscular Electrical Stimulation in Patients With Prolonged Mechanical Ventilation (NMES)

Effects of Neuromuscular Electrical Stimulation on 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.

Study Overview

• Status: Completed
• Conditions: Prolonged Mechanical Ventilation
• Intervention / Treatment: Device: neuromuscular electrical stimulation

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • TaoYuan City, Taiwan, 333
    • Chang Gung University
  • Taoyuan, Taiwan, 333
    • Dept of Respiratory therapy, Chang Gung University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: electrical stimulation; receive daily NMES for 30 min/session for 10 days.	Device: neuromuscular electrical stimulation; Participants will receive muscular electrical stimulation on quadriceps muscle and abdominal muscles for 30 min/day for 10 days
SHAM_COMPARATOR: Control; receive similar electrical stimulation (ES) procedure as those in the intervention group but with ES machine power off.	Device: neuromuscular electrical stimulation; Participants will receive muscular electrical stimulation on quadriceps muscle and abdominal muscles for 30 min/day for 10 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
tissue oxygenation	local muscle tissue oxygenation	the 1st day of intervention
tissue oxygenation	local muscle tissue oxygenation	the 10th day of intervention
muscle strength	Medical research council score. The score ranges from a 0 points (zero strength) to 5 points (good)	the 1st day of intervention
muscle strength	Medical research council score. The score ranges from a 0 points (zero strength) to 5 points (good).	the 10th day of intervention
pulmonary function (maximal inspiratory pressure)	pressure gauge	the 1st day of intervention
pulmonary function (maximal inspiratory pressure)	pressure gauge	the 10th day of intervention
oxygen consumption	the amount of oxygen that body consume, is measured by indirect calorimetry	the 1st day of intervention
oxygen consumption	the amount of oxygen that body consume, is measured by indirect calorimetry	the 10th day of intervention
energy expenditure (calories)	the amount of energy expenditure which is measured by indirect calorimetry	the 1st day of intervention
energy expenditure (calories)	the amount of energy expenditure which is measured by indirect calorimetry	the 10th day of intervention
pulmonary function (rapid shallow breathing index)	respiratory rate/tidal volume	the 1st day of intervention
pulmonary function (rapid shallow breathing index)	respiratory rate/tidal volume	the 10th day of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
weaning rate	ventilator weaning results (weaning successful/failure)	through study completion, an maximal 42 days
length of stay in respiratory care center	the total days of stay in respiratory care center	through study completion, an maximal 42 days

Collaborators and Investigators

• Sponsor: Chang Gung University
• Collaborators: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 25, 2019
• Primary Completion (ACTUAL): January 31, 2021
• Study Completion (ACTUAL): January 31, 2021

Study Registration Dates

• First Submitted: August 29, 2019
• First Submitted That Met QC Criteria: August 30, 2019
• First Posted (ACTUAL): September 3, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 28, 2021
• Last Update Submitted That Met QC Criteria: July 26, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: neuromuscular electrical stimulation; metabolic; tissue oxygenation; prolonged mechanical ventilation
• Other Study ID Numbers: 201802160A3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No