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Clinical Trials/NCT03758573
NCT03758573
Recruiting
Not Applicable

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

Universidade Federal do vale do São Francisco1 site in 1 country40 target enrollmentJanuary 15, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory Insufficiency
Sponsor
Universidade Federal do vale do São Francisco
Enrollment
40
Locations
1
Primary Endpoint
Weaning mechanical ventilation
Status
Recruiting
Last Updated
2 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
January 15, 2019
End Date
December 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rodrigo Gustavo da Silva Carvalho

Principal Investigator

Universidade Federal do vale do São Francisco

Eligibility Criteria

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

Outcomes

Primary Outcomes

Weaning mechanical ventilation

Time Frame: through study completion, an average of 15 days

time of mechanical ventilation

Secondary Outcomes

  • extubation success(through study completion, an average of 2 days)
  • length of stay in the ICU(through study completion, an average of 15 days)
  • death(yes or not death, through study completion, an average of 15 days)

Study Sites (1)

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