Effectiveness Inspirational Muscle Training (IMTversusMV)

Universidade Federal do vale do São Francisco

Status: Enrolling

Conditions: Respiratory Insufficiency

Treatments: Other: Intensive Physiotherapy (IPT); Other: Inspiratory Muscle Training (IMT)

Study type: Interventional

Funder types: Other

Identifiers

NCT03758573

IMT

Details and patient eligibility

About

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.

Full 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).

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Inspiratory Muscle Training (IMT)

Experimental group

Description:

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.

Treatment:

Other: Inspiratory Muscle Training (IMT)

Intensive Physiotherapy (IPT)

Active Comparator group

Description:

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.

Treatment:

Other: Intensive Physiotherapy (IPT)