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Electrical Stimulation in Patients With Prolonged Mechanical Ventilation

Primary Purpose

Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
electrical stimulation (high frequency)
electrical stimulation (low frequency)
sham group
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Failure focused on measuring Prolong mechanical ventilator,, Electrical stimulation,, Activities of daily life,, Hospitalization outcomes.

Eligibility Criteria

20 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chang Gung Memorial Hospital, Linkou

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

electrical stimulation

sham group

Arm Description

Participants will receive muscular electrical stimulation 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.

Outcomes

Primary Outcome Measures

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).
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.
Pulmonary Function
The pulmonary function as assessed by the measurement of tidal volume.

Secondary Outcome Measures

Hospitalization Outcomes
The total days that participants stay in the respiratory care center (RCC).

Full Information

First Posted
August 6, 2014
Last Updated
February 7, 2017
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02227810
Brief Title
Electrical Stimulation in Patients With Prolonged Mechanical Ventilation
Official Title
Effects of Muscular Electrical Stimulation on Skeletal and Lung Mechanics in Patients With Prolonged Mechanical Ventilation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure
Keywords
Prolong mechanical ventilator,, Electrical stimulation,, Activities of daily life,, Hospitalization outcomes.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
electrical stimulation
Arm Type
Experimental
Arm Description
Participants will receive muscular electrical stimulation on quadriceps muscle for 20 min/session, twice daily for 10 days
Arm Title
sham group
Arm Type
Sham Comparator
Arm Description
Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.
Intervention Type
Other
Intervention Name(s)
electrical stimulation (high frequency)
Intervention Description
Participants will receive muscular electrical stimulation (75Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days
Intervention Type
Other
Intervention Name(s)
electrical stimulation (low frequency)
Intervention Description
Participants will receive muscular electrical stimulation (35Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days.
Intervention Type
Other
Intervention Name(s)
sham group
Intervention Description
Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.
Primary Outcome Measure Information:
Title
Level of Activity of Daily Life
Description
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
Title
Muscle Strength
Description
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
Title
Pulmonary Function
Description
The pulmonary function as assessed by the measurement of tidal volume.
Time Frame
end of intervention
Secondary Outcome Measure Information:
Title
Hospitalization Outcomes
Description
The total days that participants stay in the respiratory care center (RCC).
Time Frame
the day participants were discharged from RCC

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chung-Chi Huang
Organizational Affiliation
Division of Pulmonary and Critical Care Medicine, Chang Gung Memorial Hospital,Linkou, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital, Linkou
City
Tao-Yuan
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30723168
Citation
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.
Results Reference
derived

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Electrical Stimulation in Patients With Prolonged Mechanical Ventilation

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