Respiratory Failure
Conditions
Keywords
Prolong mechanical ventilator,, Electrical stimulation,, Activities of daily life,, Hospitalization outcomes.
Brief summary
Muscle atrophy and diaphragm dysfunction are common complication in patients with prolong mechanical ventilator (PMV) and is associated with increased rate of weaning failure and days of hospitalization. Electrical stimulation (ES) has been shown to be beneficial in patients with severe chronic heart failure and chronic obstructive pulmonary disease. The purpose of this study is to examine the effects of ES on skeletal muscle function, pulmonary mechanics and hospitalization outcomes in patients with PMV.
Detailed description
BACKGROUND AND PURPOSE: Muscle atrophy and diaphragm dysfunction are common complication in patients with prolong mechanical ventilator (PMV) and is associated with increased rate of weaning failure and days of hospitalization. Electrical stimulation (ES) has been shown to be beneficial in patients with severe chronic heart failure and chronic obstructive pulmonary disease. The purpose of this study is to examine the effects of ES on skeletal muscle function, pulmonary mechanics and hospitalization outcomes in patients with PMV. METHODS: Patients who have been on mechanical ventilator for more than 21 days will be recruited from respiratory care center (RCC). All subjects will be randomly assigned into three groups: ES in abdominal muscles (ES-Abd, n=30),ES in brachial biceps (ES-bicep, n=30) and sham group(Sham). Subjects in both groups will receive ES in muscles for 30 min/session, 2 sessions/day for 10 days with the same setting except area of ES. The muscle function will be assessed by skin-fold thickness and muscle strength. The pulmonary function will be assessed by: lung compliance, airway resistance, tidal volume, minute volume and maximal inspiratory pressure. The hospitalization outcome will be followed up until patients are discharged from RCC. The outcomes variables include: weaning rate and duration, mortality, days of ventilator, and length of RCC stay.
Interventions
OTHERelectrical stimulation (high frequency)
Participants will receive muscular electrical stimulation (75Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days
OTHERelectrical stimulation (low frequency)
Participants will receive muscular electrical stimulation (35Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days.
OTHERsham group
Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* age\>20 years old * mechanical ventilation for more than 6 h/ day for more than 21 days -- medical stability (arterial blood gas value hydrogen power(pH): 7.35-7.45, atrial oxygen pressure(PaO2): 60 mmHg at 40% fraction of inspired oxygen inspired oxygen fraction (FiO2), absence of signs and symptoms of infection, and hemodynamic stability);
Exclusion criteria
* signs of acute infection (BT\>38.5℃，WBC\>12000 or \<3000 per unit * neuromuscular disease at acute stage * diagnosis of cancer at end-stage * pregnancy * BMI\>35kg/m2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary Function | end of intervention | The pulmonary function as assessed by the measurement of tidal volume. |
| Level of Activity of Daily Life | end of intervention | The level of activity of daily life was measured by Functional Independence Measure (FIM) score. Possible scores range from 18 (total assist) to 126 (complete independence). |
| Muscle Strength | end of intervention | The muscle strength of quadriceps were assessed by Medical Research Council (MRC) scoring system. The MRC score ranges from a 0 points (zero strength) to 5 points (good). The higher points indicated the better muscle strength. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization Outcomes | the day participants were discharged from RCC | The total days that participants stay in the respiratory care center (RCC). |
Countries
Taiwan
Participant flow
Recruitment details
Recruitment period: 2012/08/01--2014/07/31 Location: respiratory care center
Participants by arm
| Arm | Count |
|---|---|
| Electrical Stimulation Participants will receive muscular electrical stimulation on quadriceps muscle for 20 min/session, twice daily for 10 days
electrical stimulation (high frequency): Participants will receive muscular electrical stimulation (75Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days
electrical stimulation (low frequency): Participants will receive muscular electrical stimulation (35Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days. | 34 |
| Sham Group Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.
sham group: Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off. | 19 |
| Total | 53 |
Baseline characteristics
| Characteristic | Sham Group | Total | Electrical Stimulation |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 13 Participants | 42 Participants | 29 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 11 Participants | 5 Participants |
| Age, Continuous | 71.9 years STANDARD_DEVIATION 17.8 | 74.5 years STANDARD_DEVIATION 15.4 | 75.2 years STANDARD_DEVIATION 15.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 19 Participants | 53 Participants | 34 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Taiwan | 19 participants | 53 participants | 34 participants |
| Sex: Female, Male Female | 9 Participants | 23 Participants | 14 Participants |
| Sex: Female, Male Male | 10 Participants | 30 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 34 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Level of Activity of Daily Life
The level of activity of daily life was measured by Functional Independence Measure (FIM) score. Possible scores range from 18 (total assist) to 126 (complete independence).
Time frame: end of intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Group | Level of Activity of Daily Life | 25.2 units on a scale | Standard Deviation 14.5 |
| Electrical Stimulation | Level of Activity of Daily Life | 32.0 units on a scale | Standard Deviation 21.4 |
p-value: 0.652t-test, 2 sided
p-value: 0.123t-test, 2 sided
Primary
Muscle Strength
The muscle strength of quadriceps were assessed by Medical Research Council (MRC) scoring system. The MRC score ranges from a 0 points (zero strength) to 5 points (good). The higher points indicated the better muscle strength.
Time frame: end of intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Group | Muscle Strength | 1.7 units on a scale | Standard Deviation 1.1 |
| Electrical Stimulation | Muscle Strength | 2.7 units on a scale | Standard Deviation 1.6 |
p-value: 0.051t-test, 2 sided
p-value: <0.05t-test, 2 sided
Primary
Pulmonary Function
The pulmonary function as assessed by the measurement of tidal volume.
Time frame: end of intervention
Population: t -test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Group | Pulmonary Function | 164.7 ml | Standard Deviation 102.7 |
| Electrical Stimulation | Pulmonary Function | 214.4 ml | Standard Deviation 57.3 |
p-value: 0.051t-test, 2 sided
Secondary
Hospitalization Outcomes
The total days that participants stay in the respiratory care center (RCC).
Time frame: the day participants were discharged from RCC
Population: t test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Group | Hospitalization Outcomes | 34.2 days | Standard Deviation 18.2 |
| Electrical Stimulation | Hospitalization Outcomes | 32.3 days | Standard Deviation 22.2 |
p-value: 0.792t-test, 2 sided