Neuromuscular Electrical Stimulation in Patients With Prolonged Mechanical Ventilation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-25

Study Completion Date

2021-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Electrical Stimulation in Patients With Prolonged Mechanical Ventilation

NCT02227810

Respiratory Failure

COMPLETED NA

Effects of Neuromuscular Electrical Stimulation on Critically Ill Patients With Mechanical Ventilation

NCT05217511

Respiratory Insufficiency Requiring Mechanical Ventilation

UNKNOWN NA

NMES Role to Prevent Respiratory Muscle Weakness in Critically Ill Patients and Its Association to Changes in Myokines.

NCT05536531

Muscle Weakness or Atrophy Mechanical Ventilation Complication Electrical Stimulations

RECRUITING NA

High Protein, Core Muscle Rehab, Muscular Electrostimulation in Prolonged Mechanical Ventilation

NCT05932134

Prolonged Mechanical Ventilation Protein Deficiency

COMPLETED NA

Effects of NMES in Critically Ill Patients

NCT04382378

Mechanical Ventilation Complication Muscle Weakness Condition Covid19

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prolonged Mechanical Ventilation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

electrical stimulation

receive daily NMES for 30 min/session for 10 days.

Group Type EXPERIMENTAL

neuromuscular electrical stimulation

Intervention Type DEVICE

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

Control

receive similar electrical stimulation (ES) procedure as those in the intervention group but with ES machine power off.

Group Type SHAM_COMPARATOR

neuromuscular electrical stimulation

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

neuromuscular electrical stimulation

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No