Effectiveness Inspirational Muscle Training

Study Overview
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Brief Summary
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The long stay in mechanical ventilation can induce several complications, among them respiratory muscle weakness, this has been related to the duration of mechanical ventilation, delay and failure to wean, resulting in longer hospitalization, which reflects in greater care increase in hospital costs. Therefore, of this research will be to compare the effectiveness of early inspiratory muscle training (IMT) versus non-IMT in patients undergoing mechanical ventilation to improve the outcome of mechanical ventilation weaning time.

Detailed Description
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The study will consist of a randomized controlled clinical trial conducted at the Intensive Care Unit of the University Hospital of UNIVASF. Will be included individuals of both sexes, aged 18 years or older, who are on invasive mechanical ventilation and who obtain the Free and Informed Consent Form, signed by the responsible family member. Subjects will be randomized into two groups (training and control). The inspiratory (MIP), expiratory (MEP) and peak expiratory flow pressures will be evaluated. The training group will perform respiratory muscle training, using the Powerbreath equipment, with initial loading of 40% of MIP, 7 days a week, 2 times a day. Morbidities that have repercussions on diaphragmatic contraction and end-stage disease will be used as exclusion criteria. The sample data will be analyzed through the SPSS 22.0 program. The significance level of the study will be set at 5% (p <0.05).

Official Title
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Effectiveness of Early Inspirational Muscle Training in Patients Submitted to Mechanical Ventilation: a Randomized Clinical Trial

Conditions
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Respiratory Insufficiency

Intervention / Treatment
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* Other: Inspiratory Muscle Training (IMT)
* Other: Intensive Physiotherapy (IPT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: invasive mechanical ventilation patients hemodynamically stable without use of vasoactive drugs Exclusion Criteria: spindle trauma neuromuscular diseases end-stage disease pneumothorax rib fracture diaphragmatic injury postoperative pulmonary surgeries abdominal disease morbidities that have repercussions on diaphragmatic contraction mechanical ventilation with FiO2 > 60% and PEEP > 10 cm H2O

Ages Eligible for Study
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Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Compare the effectiveness of early inspiratory muscle training (IMT) versus non-IMT in patients undergoing mechanical ventilation to improve the outcome of mechanical ventilation weaning time.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inspiratory Muscle Training (IMT)<br>IMT by means of the Powerbreath equipment (Classic, London, UK), according to the following parameters: initial loading of 40% of MIP, 3 sets of 10 repetitions with interval of 1 minute between each sets, 7 days a week, 2 times a day , with the patients in the bed with the angulation of 45 °. The IMT load settings will be adjusted according to the values evaluated weekly. If there is need for addition of supplemental oxygen will be performed to perform the IMT. | Other: Inspiratory Muscle Training (IMT)<br>* Inspiratory Muscle Training (IMT)<br>|
| Active Comparator: Intensive Physiotherapy (IPT)<br>IPT will be to individualized and supervised intervention program consisting of any of the following procedures: passive, assisted, active or resisted mobilization, sedation and orthostasis depending on the functional level of the patient, as well as bronchial hygiene therapy and pulmonary expansion therapy. | Other: Intensive Physiotherapy (IPT)<br>* Intensive Physiotherapy (IPT)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weaning mechanical ventilation | time of mechanical ventilation | through study completion, an average of 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of stay in the ICU | reduction length of stay in the ICU | through study completion, an average of 15 days | 
| extubation success | extubation success after 48 hours | through study completion, an average of 2 days | 
| death | reduction in mortality (death) | yes or not death, through study completion, an average of 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Respiration Artificial, Breathing Exercises, Respiratory Muscles, Weaning