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Electrical Stimulation in Patients With Prolonged Mechanical Ventilation

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ClinicalTrials.gov Identifier: NCT02227810
Recruitment Status : Completed
First Posted : August 28, 2014
Results First Posted : March 27, 2017
Last Update Posted : March 27, 2017
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Respiratory Failure Other: electrical stimulation (high frequency) Other: electrical stimulation (low frequency) Other: sham group Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effects of Muscular Electrical Stimulation on Skeletal and Lung Mechanics in Patients With Prolonged Mechanical Ventilation
Study Start Date : August 2012
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Arm Intervention/treatment
Experimental: electrical stimulation
Participants will receive muscular electrical stimulation on quadriceps muscle for 20 min/session, twice daily for 10 days
Other: electrical stimulation (high frequency)
Participants will receive muscular electrical stimulation (75Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days

Other: electrical stimulation (low frequency)
Participants will receive muscular electrical stimulation (35Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days.

Sham Comparator: sham group
Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.
Other: sham group
Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.




Primary Outcome Measures :
  1. Level of Activity of Daily Life [ Time Frame: 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).

  2. Muscle Strength [ Time Frame: 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.

  3. Pulmonary Function [ Time Frame: end of intervention ]
    The pulmonary function as assessed by the measurement of tidal volume.


Secondary Outcome Measures :
  1. Hospitalization Outcomes [ Time Frame: the day participants were discharged from RCC ]
    The total days that participants stay in the respiratory care center (RCC).



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Ages Eligible for Study:   20 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02227810


Locations
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Taiwan
Chang Gung Memorial Hospital, Linkou
Tao-Yuan, Taiwan, 333
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: Chung-Chi Huang Division of Pulmonary and Critical Care Medicine, Chang Gung Memorial Hospital,Linkou, Taiwan

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02227810     History of Changes
Other Study ID Numbers: 103-1702C
First Posted: August 28, 2014    Key Record Dates
Results First Posted: March 27, 2017
Last Update Posted: March 27, 2017
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Chang Gung Memorial Hospital:
Prolong mechanical ventilator,
Electrical stimulation,
Activities of daily life,
Hospitalization outcomes.

Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases