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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
Fooyin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Ventilator Dependency

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
June 4, 2019
Last Updated
June 21, 2019
Sponsor
Fooyin University
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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

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The Impact of Inspiratory Muscle Strength Training

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