Specific Inspiratory Muscle Training (SIMT)in the Patients With Ventilatory Dependence (SIMT)
Primary Purpose
Ventilatory Defect
Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
intervention group
Sponsored by
About this trial
This is an interventional treatment trial for Ventilatory Defect focused on measuring Specific inspiratory muscle training(SIMT), Loaded deep breathing, Weaning, Mechanical ventilation, Respiratory muscle
Eligibility Criteria
Inclusion Criteria:
- Patient who have been mechanically ventilated > 72 hours and start to weaning from medical order or ventilator dependent patients who have failed to wean prior to study.
- Normal arterial blood gas (PaCO2 < 50mmHg, PaO2 > 60 mmHg on FiO2 <0.5 or SaO2 > 90%, PH 7.35-7.45).
- Cardiovascular stability (HR ≤ 140 beats/min, systolic BP 90-140 mmHg and diastolic BP 60-90 mmHg, with no or minimal vasopressors)
- Good consciousness, cooperation and can sit in an upright position > 30 minutes
Exclusion Criteria:
- Persistent homodynamic instability.
- Severe breathlessness at rest when spontaneous breathing.
- Coronary heart disease with angina.
- Life threatening arrhythmia (VF, VT).
- Sedation Ramsay scale > 2
- Severity of disease APACHE II score > 29
Sites / Locations
- Respiratory Intensive Care Unit (RICU),Srinagarind Hospital
Arms of the Study
Arm 1
Arm Type
No Intervention
Arm Label
intervention group
Arm Description
Patients with mechanical ventilated who met the criteria for weaning from medical doctor in Srinagarind hospital, Khon Kaen University
Outcomes
Primary Outcome Measures
Peak Negative Inspiratory Pressure (PNIP)
Secondary Outcome Measures
Lung compliance
Vital capacity
Rate perceived breathlessness
Airway resistance
Tidal volume
Minute ventilation
End tidal carbondioxide (PetCO2)
SpO2
Heart rate
Respiratory rate
Weaning success
Full Information
NCT ID
NCT00792441
First Posted
November 17, 2008
Last Updated
April 1, 2015
Sponsor
Saikaew Chuachan
Collaborators
Khon Kaen University
1. Study Identification
Unique Protocol Identification Number
NCT00792441
Brief Title
Specific Inspiratory Muscle Training (SIMT)in the Patients With Ventilatory Dependence
Acronym
SIMT
Official Title
Effect of Specific Inspiratory Inspiratory Training(SIMT)in the Patients With Ventilatory Dependence on Lung Function and Weaning Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Saikaew Chuachan
Collaborators
Khon Kaen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Prolong mechanical ventilation cause to respiratory muscle weakness and high risk to weaning failure,the investigators hypothesize that
Specific inspiratory muscle training (SIMT) using threshold loaded breathing device (BreatheMAX V.1)in patients with ventilator dependence will improve inspiratory muscle strength
SIMT will improve lung function in patients with ventilatory dependence.
SIMT will improve weaning success in patients with ventilatory dependence.
Detailed Description
Prolonged mechanical ventilation cause detrimental effects on lung function and high risk of lung complications and standard weaning protocols are not successful in a number of patients. The strength of the inspiratory muscles is important factors in the success of weaning. Although, the inspiratory muscles are trained by manipulating the ventilator sensitivity and made of ventilation in the traditional protocol, the muscle function might not improved sufficiently to sustain independent and spontaneous breathing. Consequently, specific inspiratory muscle training is indicated and has been studied in patient with weaning failure. However, there is little evidence available and no firm conclusion can be drown. Therefore, the purpose of this study is to determine whether specific IMT training using the local made loaded threshold IMT device can improve lung function and accelerate the weaning process.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilatory Defect
Keywords
Specific inspiratory muscle training(SIMT), Loaded deep breathing, Weaning, Mechanical ventilation, Respiratory muscle
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intervention group
Arm Type
No Intervention
Arm Description
Patients with mechanical ventilated who met the criteria for weaning from medical doctor in Srinagarind hospital, Khon Kaen University
Intervention Type
Device
Intervention Name(s)
intervention group
Other Intervention Name(s)
BreatheMax v.1, water pressure threshold breathing (WPTB)
Intervention Description
inspiratory muscle training at 50% of peak negative inspiratory muscle training (PNIP)will be performed with 6 breathe/set, 10 set/day, once a day for 28 days.
Primary Outcome Measure Information:
Title
Peak Negative Inspiratory Pressure (PNIP)
Time Frame
every 7 day for 28 days
Secondary Outcome Measure Information:
Title
Lung compliance
Time Frame
every 7 day for 28 days
Title
Vital capacity
Time Frame
every 7 day for 28 days
Title
Rate perceived breathlessness
Time Frame
every 7 day for 28 day
Title
Airway resistance
Time Frame
every 7 day for 28 days.
Title
Tidal volume
Time Frame
every 7 day for 28 days.
Title
Minute ventilation
Time Frame
every 7 day for 28 days.
Title
End tidal carbondioxide (PetCO2)
Time Frame
every 7 day for 28 days.
Title
SpO2
Time Frame
every 7 day for 28 days.
Title
Heart rate
Time Frame
every 7 day for 28 days.
Title
Respiratory rate
Time Frame
every 7 day for 28 days.
Title
Weaning success
Time Frame
every 7 day for 28 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient who have been mechanically ventilated > 72 hours and start to weaning from medical order or ventilator dependent patients who have failed to wean prior to study.
Normal arterial blood gas (PaCO2 < 50mmHg, PaO2 > 60 mmHg on FiO2 <0.5 or SaO2 > 90%, PH 7.35-7.45).
Cardiovascular stability (HR ≤ 140 beats/min, systolic BP 90-140 mmHg and diastolic BP 60-90 mmHg, with no or minimal vasopressors)
Good consciousness, cooperation and can sit in an upright position > 30 minutes
Exclusion Criteria:
Persistent homodynamic instability.
Severe breathlessness at rest when spontaneous breathing.
Coronary heart disease with angina.
Life threatening arrhythmia (VF, VT).
Sedation Ramsay scale > 2
Severity of disease APACHE II score > 29
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reechaipichitkul Wipa, MD
Organizational Affiliation
Department of medicine, Faculty of medicine, Khon Kaen university
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Chulee CU Jones, Philosophy
Organizational Affiliation
Physical Therapy department, Faculty of Associated Medical Sciences, Khon Kaen university
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Saikaew Chuachan, Bachelor
Organizational Affiliation
Physical Therapy department, Faculty of Associated Medical Sciences, Khon Kaen university
Official's Role
Study Chair
Facility Information:
Facility Name
Respiratory Intensive Care Unit (RICU),Srinagarind Hospital
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
12. IPD Sharing Statement
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Specific Inspiratory Muscle Training (SIMT)in the Patients With Ventilatory Dependence
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