Clinical trial NCT04076475: Neuromuscular Electrical Stimulation in Patients With Prolonged Mechanical Ventilation
Official title: Effects of Neuromuscular Electrical Stimulation on Patients With Prolonged Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prolonged Mechanical Ventilation
Keywords: neuromuscular electrical stimulation
tissue oxygenation
prolonged mechanical ventilation
metabolic
Lead sponsor: Chang Gung University
Sponsor class: OTHER
Collaborators: name: Chang Gung Memorial Hospital
First posted: 2019-09-03
Enrollment: 8
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: tissue oxygenation
timeFrame: the 1st day of intervention
measure: tissue oxygenation
timeFrame: the 10th day of intervention
measure: muscle strength
timeFrame: the 1st day of intervention
measure: muscle strength
timeFrame: the 10th day of intervention
measure: pulmonary function (maximal inspiratory pressure)
timeFrame: the 1st day of intervention
measure: pulmonary function (maximal inspiratory pressure)
timeFrame: the 10th day of intervention
measure: oxygen consumption
timeFrame: the 1st day of intervention
measure: oxygen consumption
timeFrame: the 10th day of intervention
measure: energy expenditure (calories)
timeFrame: the 1st day of intervention
measure: energy expenditure (calories)
timeFrame: the 10th day of intervention
measure: pulmonary function (rapid shallow breathing index)
timeFrame: the 1st day of intervention
measure: pulmonary function (rapid shallow breathing index)
timeFrame: the 10th day of intervention
Secondary outcomes:
measure: weaning rate
timeFrame: through study completion, an maximal 42 days
measure: length of stay in respiratory care center
timeFrame: through study completion, an maximal 42 days
Other outcomes:
Locations:
city: TaoYuan City
country: Taiwan
facility: Chang Gung University
city: Taoyuan
country: Taiwan
facility: Dept of Respiratory therapy, Chang Gung University
Study officials:
affiliation: Chang Gung University
name: Yen-Huey Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References: