Trial Outcomes & Findings for Electrical Stimulation in Patients With Prolonged Mechanical Ventilation (NCT NCT02227810)
NCT ID: NCT02227810
Last Updated: 2017-03-27
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
53 participants
Primary outcome timeframe
end of intervention
Results posted on
2017-03-27
Participant Flow
Recruitment period: 2012/08/01--2014/07/31 Location: respiratory care center
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
34
|
|
Overall Study
COMPLETED
|
17
|
29
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Electrical Stimulation in Patients With Prolonged Mechanical Ventilation
Baseline characteristics by cohort
| Measure |
Electrical Stimulation
n=34 Participants
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.
|
Sham Group
n=19 Participants
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.
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
29 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Age, Continuous
|
75.2 years
STANDARD_DEVIATION 15.4 • n=5 Participants
|
71.9 years
STANDARD_DEVIATION 17.8 • n=7 Participants
|
74.5 years
STANDARD_DEVIATION 15.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
34 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
34 participants
n=5 Participants
|
19 participants
n=7 Participants
|
53 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: end of interventionThe 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).
Outcome measures
| Measure |
Sham Group
n=19 Participants
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.
|
Electrical Stimulation
n=34 Participants
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.
|
|---|---|---|
|
Level of Activity of Daily Life
|
25.2 units on a scale
Standard Deviation 14.5
|
32.0 units on a scale
Standard Deviation 21.4
|
PRIMARY outcome
Timeframe: end of interventionThe 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.
Outcome measures
| Measure |
Sham Group
n=19 Participants
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.
|
Electrical Stimulation
n=34 Participants
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.
|
|---|---|---|
|
Muscle Strength
|
1.7 units on a scale
Standard Deviation 1.1
|
2.7 units on a scale
Standard Deviation 1.6
|
PRIMARY outcome
Timeframe: end of interventionPopulation: t -test
The pulmonary function as assessed by the measurement of tidal volume.
Outcome measures
| Measure |
Sham Group
n=19 Participants
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.
|
Electrical Stimulation
n=34 Participants
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.
|
|---|---|---|
|
Pulmonary Function
|
164.7 ml
Standard Deviation 102.7
|
214.4 ml
Standard Deviation 57.3
|
SECONDARY outcome
Timeframe: the day participants were discharged from RCCPopulation: t test
The total days that participants stay in the respiratory care center (RCC).
Outcome measures
| Measure |
Sham Group
n=19 Participants
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.
|
Electrical Stimulation
n=34 Participants
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.
|
|---|---|---|
|
Hospitalization Outcomes
|
34.2 days
Standard Deviation 18.2
|
32.3 days
Standard Deviation 22.2
|
Adverse Events
Sham Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Electrical Stimulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place