Neuromuscular Electrical Stimulation in Patients With Prolonged Mechanical Ventilation
NMES
Effects of Neuromuscular Electrical Stimulation on Patients With Prolonged Mechanical Ventilation
1 other identifier
interventional
8
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2019
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 25, 2019
CompletedFirst Submitted
Initial submission to the registry
August 29, 2019
CompletedFirst Posted
Study publicly available on registry
September 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2021
CompletedJuly 28, 2021
February 1, 2021
1.9 years
August 29, 2019
July 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (12)
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 Outcomes (2)
weaning rate
through study completion, an maximal 42 days
length of stay in respiratory care center
through study completion, an maximal 42 days
Study Arms (2)
electrical stimulation
EXPERIMENTALreceive daily NMES for 30 min/session for 10 days.
Control
SHAM COMPARATORreceive similar electrical stimulation (ES) procedure as those in the intervention group but with ES machine power off.
Interventions
Participants will receive muscular electrical stimulation on quadriceps muscle and abdominal muscles for 30 min/day for 10 days
Eligibility Criteria
You may qualify if:
- age ≧ 20 years;
- MV for \> 6 h/day for \> 21 days; and
- medical stability, absence of signs and symptoms of infection, and hemodynamic stability).
- hemodynamic stable without or with a low dose of vasopressor ((Dopamine or Dobutamine \<5μg/kg/min)
You may not qualify if:
- acute lung or systemic infection,
- ongoing neuromuscular disease (e.g., myasthenia gravis, Guillain-Barre disease)
- bone contracture or skin lesion
- obesity \[body mass index (BMI) \>35 kg/m2\].
- disease at end-stage with expecting survival \<=6month
- pregnancy
- severe edema (deep indentation when pressing a finger into the skin, requiring \>30 s to rebound
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chang Gung Universitylead
- Chang Gung Memorial Hospitalcollaborator
Study Sites (2)
Chang Gung University
Taoyuan, 333, Taiwan
Dept of Respiratory therapy, Chang Gung University
Taoyuan District, 333, Taiwan
Study Officials
- PRINCIPAL INVESTIGATOR
Yen-Huey Chen, PhD
Chang Gung University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assist professor
Study Record Dates
First Submitted
August 29, 2019
First Posted
September 3, 2019
Study Start
February 25, 2019
Primary Completion
January 31, 2021
Study Completion
January 31, 2021
Last Updated
July 28, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share