Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| electrical stimulation | Experimental | Participants will receive muscular electrical stimulation on quadriceps muscle for 20 min/session, twice daily for 10 days |
|
| sham group | Sham Comparator | Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| electrical stimulation (high frequency) | Other | Participants will receive muscular electrical stimulation (75Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | end of intervention |
| 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. | end of intervention |
| Pulmonary Function | The pulmonary function as assessed by the measurement of tidal volume. | end of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalization Outcomes | The total days that participants stay in the respiratory care center (RCC). | the day participants were discharged from RCC |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Chung-Chi Huang | Division of Pulmonary and Critical Care Medicine, Chang Gung Memorial Hospital,Linkou, Taiwan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital, Linkou | Taoyuan | 333 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30723168 | Derived | Chen YH, Hsiao HF, Li LF, Chen NH, Huang CC. Effects of Electrical Muscle Stimulation in Subjects Undergoing Prolonged Mechanical Ventilation. Respir Care. 2019 Mar;64(3):262-271. doi: 10.4187/respcare.05921. Epub 2019 Feb 5. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Recruitment period: 2012/08/01--2014/07/31 Location: respiratory care center
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | units on a scale | end of intervention |
|
Not provided
Adverse Events were no collected /assessed.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sham Group | Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Huang Chung-Chi | Chang Gung memorial hospital | 88632118800 | 5233 | yhchen@mail.cgu.edu.tw |
Not provided
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004558 | Electric Stimulation |
| ID | Term |
|---|---|
| D010812 | Physical Stimulation |
| D008919 | Investigative Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| electrical stimulation (low frequency) | Other | Participants will receive muscular electrical stimulation (35Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days. |
|
| sham group | Other | Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off. |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | end of intervention |
|
|
|
|
| Primary | Pulmonary Function | The pulmonary function as assessed by the measurement of tidal volume. | t -test | Posted | Mean | Standard Deviation | ml | end of intervention |
|
|
|
|
| Secondary | Hospitalization Outcomes | The total days that participants stay in the respiratory care center (RCC). | t test | Posted | Mean | Standard Deviation | days | the day participants were discharged from RCC |
|
|
|
|
| 0 |
| 19 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Electrical Stimulation | Participants will receive muscular electrical stimulation on quadriceps muscle for 20 min/session, twice daily for 10 days | 0 | 34 | 0 | 0 | 0 | 0 |
Not provided
Not provided
| Superiority |