Clinical trial NCT03758573: Effectiveness Inspirational Muscle Training
Official title: Effectiveness of Early Inspirational Muscle Training in Patients Submitted to Mechanical Ventilation: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Insufficiency
Keywords: Breathing Exercises
Respiratory Muscles
Respiration Artificial
Weaning
Lead sponsor: Universidade Federal do vale do São Francisco
Sponsor class: OTHER
First posted: 2018-11-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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).

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

Primary outcomes:
measure: Weaning mechanical ventilation
timeFrame: through study completion, an average of 15 days
Secondary outcomes:
measure: length of stay in the ICU
timeFrame: through study completion, an average of 15 days
measure: extubation success
timeFrame: through study completion, an average of 2 days
measure: death
timeFrame: yes or not death, through study completion, an average of 15 days
Other outcomes:
Locations:
city: Petrolina
country: Brazil
facility: Physical Education College
state: Pernambuco
Study officials:
affiliation: Physical Education College / UNIVASF
name: Rodrigo GS Carvalho, PhD
role: PRINCIPAL_INVESTIGATOR
References: