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Effectiveness Inspirational Muscle Training

Not Applicable
Recruiting
Conditions
Respiratory Insufficiency
Interventions
Other: Inspiratory Muscle Training (IMT)
Other: Intensive Physiotherapy (IPT)
Registration Number
NCT03758573
Lead Sponsor
Universidade Federal do vale do São Francisco
Brief Summary

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

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).

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
40
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Inspiratory Muscle Training (IMT)Inspiratory Muscle Training (IMT)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.
Intensive Physiotherapy (IPT)Intensive Physiotherapy (IPT)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.
Primary Outcome Measures
NameTimeMethod
Weaning mechanical ventilationthrough study completion, an average of 15 days

time of mechanical ventilation

Secondary Outcome Measures
NameTimeMethod
extubation successthrough study completion, an average of 2 days

extubation success after 48 hours

length of stay in the ICUthrough study completion, an average of 15 days

reduction length of stay in the ICU

deathyes or not death, through study completion, an average of 15 days

reduction in mortality (death)

Trial Locations

Locations (1)

Physical Education College

🇧🇷

Petrolina, Pernambuco, Brazil

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