Effectiveness Inspirational Muscle Training

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 31, 2021

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).

Interventions

  • Other: Inspiratory Muscle Training (IMT)
    • Inspiratory Muscle Training (IMT)
  • Other: Intensive Physiotherapy (IPT)
    • Intensive Physiotherapy (IPT)

Arms, Groups and Cohorts

  • Experimental: 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.
  • Active Comparator: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Weaning mechanical ventilation
    • Time Frame: through study completion, an average of 15 days
    • time of mechanical ventilation

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Universidade Federal do vale do São Francisco
  • Provider of Information About this Clinical Study
    • Principal Investigator: Rodrigo Gustavo da Silva Carvalho, Principal Investigator – Universidade Federal do vale do São Francisco
  • Overall Official(s)
    • Rodrigo GS Carvalho, PhD, Principal Investigator, Physical Education College / UNIVASF
  • Overall Contact(s)
    • Rodrigo GS Carvalho, PhD, +5587999832015, rodrigocarvalhofisio@gmail.com

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