The Impact of Inspiratory Muscle Strength Training (IMT)
Primary Purpose
Ventilator Dependency
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
inspiratory muscle strength training
Sponsored by
About this trial
This is an interventional other trial for Ventilator Dependency
Eligibility Criteria
Inclusion Criteria:
- Age >20y/o
- Vital signs stable
- MIP <20cmH2O
- Ventilator FiO2<40%, PEEP <8
- Ventilator mode:PSV or SIMV
Exclusion Criteria:
- Patient or family refuse
Sites / Locations
- Shinghou Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
experimental group
Arm Description
as usual care
The intervention of inspiratory muscle strength training
Outcomes
Primary Outcome Measures
Maximal inspiratory pressure
a measure of the strength of inspiratory muscles, measurement by cmH2O.
Tidal volume
the volume of air that is transported into and out of the lungs with each respiratory cycle, measurement by mL per inspiration
Minute ventilation volume
the quantity of air moved into and out of the lungs in a minute, measurement by l.min
Rapid shallow breathing index
the ratio of respiratory frequency to tidal volume (f/VT)
Oxygenation index.
Oxygenation index OI = FiO2 x 100 x M AP/PaO2, where FiO2 is the fraction of inspired oxygen, MAP is the mean airway pressure, and PaO2 is the partial pressure of oxygen in arterial blood, calculated at the end of the first day of standardized preoperative stabilization
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03997214
Brief Title
The Impact of Inspiratory Muscle Strength Training
Acronym
IMT
Official Title
The Impact of Inspiratory Muscle Strength Training on Weaning Parameters Among Ventilator-dependent Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
June 15, 2018 (Actual)
Primary Completion Date
December 30, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fooyin University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study is a pre-post test with quasi experimental design. Forty-two intubated-adults who had been mechanically ventilated for more than 21 days were selected on the basis of inclusion criteria in respiratory care ward. These patients were classified equally into study group and control group. The experimental group received the intervention of respiratory muscles training 5 times/ a week for 6 weeks. The control group received normal care. The intervention was adjusted trigger sensitivity to 10% of the first recorded Maximal Inspiratory Pressure at the start of training, then increased the ventilator trigger sensitivity and training duration weekly. The largest of ventilator trigger sensitivity is not over 40% of the initial Maximal Inspiratory Pressure and the timing of training duration is no longer than 30 minutes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator Dependency
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
as usual care
Arm Title
experimental group
Arm Type
Experimental
Arm Description
The intervention of inspiratory muscle strength training
Intervention Type
Device
Intervention Name(s)
inspiratory muscle strength training
Intervention Description
The experimental group received the intervention of inspiratory muscles training 5times/week for 6 weeks, 5days/ per cycle; the patients stayed in the semi-recumbent position, recorded the initial/first measurement of MIP. The trigger sensitivity was adjusted to 10% of the first recorded MIP at the start of training, then reducing the ventilator trigger sensitivity and training duration weekly.
Primary Outcome Measure Information:
Title
Maximal inspiratory pressure
Description
a measure of the strength of inspiratory muscles, measurement by cmH2O.
Time Frame
7 weeks
Title
Tidal volume
Description
the volume of air that is transported into and out of the lungs with each respiratory cycle, measurement by mL per inspiration
Time Frame
7 weeks
Title
Minute ventilation volume
Description
the quantity of air moved into and out of the lungs in a minute, measurement by l.min
Time Frame
7 weeks
Title
Rapid shallow breathing index
Description
the ratio of respiratory frequency to tidal volume (f/VT)
Time Frame
7 weeks
Title
Oxygenation index.
Description
Oxygenation index OI = FiO2 x 100 x M AP/PaO2, where FiO2 is the fraction of inspired oxygen, MAP is the mean airway pressure, and PaO2 is the partial pressure of oxygen in arterial blood, calculated at the end of the first day of standardized preoperative stabilization
Time Frame
7 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age >20y/o
Vital signs stable
MIP <20cmH2O
Ventilator FiO2<40%, PEEP <8
Ventilator mode:PSV or SIMV
Exclusion Criteria:
Patient or family refuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsiao-Yun Chang, Ph.D
Organizational Affiliation
Fooyin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shinghou Hospital
City
Kaohsiung
State/Province
Fengshan
ZIP/Postal Code
830
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Impact of Inspiratory Muscle Strength Training
We'll reach out to this number within 24 hrs