Electrical Stimulation in Patients With Prolonged Mechanical Ventilation
Effects of Muscular Electrical Stimulation on Skeletal and Lung Mechanics in Patients With Prolonged Mechanical Ventilation
1 other identifier
interventional
53
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 6, 2014
CompletedFirst Posted
Study publicly available on registry
August 28, 2014
CompletedResults Posted
Study results publicly available
March 27, 2017
CompletedMarch 27, 2017
March 1, 2016
1.9 years
August 6, 2014
August 15, 2016
February 7, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Secondary Outcomes (1)
Hospitalization Outcomes
the day participants were discharged from RCC
Study Arms (2)
electrical stimulation
EXPERIMENTALParticipants will receive muscular electrical stimulation on quadriceps muscle for 20 min/session, twice daily for 10 days
sham group
SHAM COMPARATORParticipants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.
Interventions
Participants will receive muscular electrical stimulation (75Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days
Participants will receive muscular electrical stimulation (35Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days.
Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.
Eligibility Criteria
You may qualify if:
- 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);
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chang Gung Memorial Hospital, Linkou
Taoyuan District, 333, Taiwan
Related Publications (1)
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.
PMID: 30723168DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Huang Chung-Chi
- Organization
- Chang Gung memorial hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Chung-Chi Huang
Division of Pulmonary and Critical Care Medicine, Chang Gung Memorial Hospital,Linkou, Taiwan
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2014
First Posted
August 28, 2014
Study Start
August 1, 2012
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
March 27, 2017
Results First Posted
March 27, 2017
Record last verified: 2016-03
Data Sharing
- IPD Sharing
- Will not share