Chronic Respiratory Failure, Critical Illness Myopathy
Conditions
Keywords
Electric muscle stimulation, mechanical ventilation, chronic respiratory failure
Brief summary
Background: After mechanical ventilation, 5-20% of patients with acute respiratory failure would depend on ventilator support more than 14 days because of critical-illness weakness and their underlying diseases such as heart failure and chronic obstructive pulmonary disease. Hypothesis: Electric muscle stimulation(EMS) will improve their muscle strength and shorten their ventilator days. Design: Randomized controlled trial. Adult patients with mechanical ventilation more than 14 days are eligible. EMS would be applied in experimental group 32 minutes/day on their bilateral thigh.
Detailed description
Randomized controlled trial involves the adult patients with invasive mechanical ventilation more than 14 days. The participants were not eligible for active rehabilitation because of drowisness or weakness(Medical Research Council (MRC) Scale for Muscle Strength≦ Grade 3). EMS would be applied in experimental group 32 minutes/day on their bilateral thigh(quadriceps muscle).
Interventions
DEVICEEMS
HELEX 573 : strength aggravation mode with middle frequency carrier(1500Hz), minimal voltage for visible muscle contraction(maximum output is 75mA) , 32 minutes per day.
Sponsors
Mackay Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Adult patient required mechanical ventilation more than 14 days * No ability for active endurance exercise because of poor consciousness or limb weakness.
Exclusion criteria
* Pregnant women * Limb wound/infection interfered with electric pad application * Recent acute myocardial infarction or life-threatening arrhythmia * Uncontrolled epilepsy * Dying patients without attempt of ventilator weaning * Absence of respiratory drive
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ventilator-free Days | 28 days | the cumulative ventilator-free days after intervention, in following 28 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Grip Power | 7 days after intervention | Weekly improvement of both hand grip muscle power in kilogram(Kg) |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Electric Muscle Stimulation(EMS) EMS:use programmed middle frequency electric stimulation device(HELEX 573)for both quadriceps stimulation, 32 minutes per day, 5 time per week.
EMS: HELEX 573 : strength aggravation mode with middle frequency carrier(1500Hz), minimal voltage for visible muscle contraction(maximum output is 75mA) , 32 minutes per day. | 7 |
| Control Patients with routine passive rehabilitation program. | 6 |
| Total | 13 |
Baseline characteristics
| Characteristic | Control | Electric Muscle Stimulation(EMS) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 6 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Continuous | 73.5 years | 82 years | 75 years |
| Region of Enrollment Taiwan | 6 participants | 7 participants | 13 participants |
| Sex: Female, Male Female | 5 Participants | 3 Participants | 8 Participants |
| Sex: Female, Male Male | 1 Participants | 4 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 6 |
| other Total, other adverse events | 0 / 7 | 0 / 6 |
| serious Total, serious adverse events | 0 / 7 | 0 / 6 |
Outcome results
Primary
Ventilator-free Days
the cumulative ventilator-free days after intervention, in following 28 days.
Time frame: 28 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Electric Muscle Stimulation(EMS) | Ventilator-free Days | 6 day |
| Control | Ventilator-free Days | 0 day |
Secondary
Grip Power
Weekly improvement of both hand grip muscle power in kilogram(Kg)
Time frame: 7 days after intervention