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Neuromuscular Electrical Stimulation in Patients With Prolonged Mechanical Ventilation

Effects of Neuromuscular Electrical Stimulation on Patients With Prolonged Mechanical Ventilation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04076475
Acronym
NMES
Enrollment
8
Registered
2019-09-03
Start date
2019-02-25
Completion date
2021-01-31
Last updated
2021-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prolonged Mechanical Ventilation

Keywords

neuromuscular electrical stimulation, tissue oxygenation, prolonged mechanical ventilation, metabolic

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.

Interventions

DEVICEneuromuscular electrical stimulation

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

Sponsors

Chang Gung Memorial Hospital
CollaboratorOTHER
Chang Gung University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
pulmonary function (rapid shallow breathing index)the 1st day of interventionrespiratory rate/tidal volume
oxygen consumptionthe 1st day of interventionthe amount of oxygen that body consume, is measured by indirect calorimetry
energy expenditure (calories)the 1st day of interventionthe amount of energy expenditure which is measured by indirect calorimetry
tissue oxygenationthe 1st day of interventionlocal muscle tissue oxygenation
muscle strengththe 1st day of interventionMedical research council score. The score ranges from a 0 points (zero strength) to 5 points (good)
pulmonary function (maximal inspiratory pressure)the 1st day of interventionpressure gauge

Secondary

MeasureTime frameDescription
length of stay in respiratory care centerthrough study completion, an maximal 42 daysthe total days of stay in respiratory care center
weaning ratethrough study completion, an maximal 42 daysventilator weaning results (weaning successful/failure)

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026