Neuromuscular Electrical Stimulation in Patients With Prolonged Mechanical Ventilation

Prolonged Mechanical Ventilation Clinical Trial

— NMES  

Official title:

Effects of Neuromuscular Electrical Stimulation on Patients With Prolonged Mechanical Ventilation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04076475
• Other study ID #: 201802160A3
• Status: Completed
• Phase: N/A
• Start date: February 25, 2019
• Est. completion date: January 31, 2021

Study information

• Verified date: February 2021
• Source: Chang Gung University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: January 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prolonged Mechanical Ventilation

Intervention

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

Locations

Country	Name	City	State
Taiwan	Dept of Respiratory therapy, Chang Gung University	Taoyuan
Taiwan	Chang Gung University	TaoYuan City

Sponsors (2)

Lead Sponsor	Collaborator
Chang Gung University	Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tissue oxygenation	local muscle tissue oxygenation	the 1st day of intervention
Primary	tissue oxygenation	local muscle tissue oxygenation	the 10th day of intervention
Primary	muscle strength	Medical research council score. The score ranges from a 0 points (zero strength) to 5 points (good)	the 1st day of intervention
Primary	muscle strength	Medical research council score. The score ranges from a 0 points (zero strength) to 5 points (good).	the 10th day of intervention
Primary	pulmonary function (maximal inspiratory pressure)	pressure gauge	the 1st day of intervention
Primary	pulmonary function (maximal inspiratory pressure)	pressure gauge	the 10th day of intervention
Primary	oxygen consumption	the amount of oxygen that body consume, is measured by indirect calorimetry	the 1st day of intervention
Primary	oxygen consumption	the amount of oxygen that body consume, is measured by indirect calorimetry	the 10th day of intervention
Primary	energy expenditure (calories)	the amount of energy expenditure which is measured by indirect calorimetry	the 1st day of intervention
Primary	energy expenditure (calories)	the amount of energy expenditure which is measured by indirect calorimetry	the 10th day of intervention
Primary	pulmonary function (rapid shallow breathing index)	respiratory rate/tidal volume	the 1st day of intervention
Primary	pulmonary function (rapid shallow breathing index)	respiratory rate/tidal volume	the 10th day of intervention
Secondary	weaning rate	ventilator weaning results (weaning successful/failure)	through study completion, an maximal 42 days
Secondary	length of stay in respiratory care center	the total days of stay in respiratory care center	through study completion, an maximal 42 days