Specific Inspiratory Muscle Training (SIMT)in the Patients With Ventilatory Dependence

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Specific Inspiratory Inspiratory Training(SIMT)in the Patients With Ventilatory Dependence on Lung Function and Weaning Outcomes

Conditions
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Ventilatory Defect

Intervention / Treatment
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* Device: intervention group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: intervention group<br>Patients with mechanical ventilated who met the criteria for weaning from medical doctor in Srinagarind hospital, Khon Kaen University | Device: intervention group<br>* 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.<br>* Other names: water pressure threshold breathing (WPTB);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Negative Inspiratory Pressure (PNIP) |  | every 7 day for 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung compliance |  | every 7 day for 28 days | 
| Vital capacity |  | every 7 day for 28 days | 
| Rate perceived breathlessness |  | every 7 day for 28 day | 
| Airway resistance |  | every 7 day for 28 days. | 
| Tidal volume |  | every 7 day for 28 days. | 
| Minute ventilation |  | every 7 day for 28 days. | 
| End tidal carbondioxide (PetCO2) |  | every 7 day for 28 days. | 
| SpO2 |  | every 7 day for 28 days. | 
| Heart rate |  | every 7 day for 28 days. | 
| Respiratory rate |  | every 7 day for 28 days. | 
| Weaning success |  | every 7 day for 28 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Specific inspiratory muscle training(SIMT), Loaded deep breathing, Weaning, Mechanical ventilation, Respiratory muscle