Effectiveness Inspirational Muscle Training

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-15

Study Completion Date

2023-12-31

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.

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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).

Conditions

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Respiratory Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Inspiratory Muscle Training (IMT)

Intervention Type OTHER

Inspiratory Muscle Training (IMT)

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.

Group Type ACTIVE_COMPARATOR

Intensive Physiotherapy (IPT)

Intervention Type OTHER

Intensive Physiotherapy (IPT)

Interventions

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Inspiratory Muscle Training (IMT)

Intervention Type OTHER

Intensive Physiotherapy (IPT)

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No