Effectiveness Inspirational Muscle Training

Not Applicable

Recruiting

• Conditions: Respiratory Insufficiency

• Registration Number: NCT03758573
• Lead Sponsor: Universidade Federal do vale do São Francisco

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).

Study Timeline

• Study First Submitted: 2018-11-21
• Study First Submitted QC: 2018-11-27
• Study First Posted: 2018-11-29
• Study Start: 2019-01-15
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-10
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Weaning mechanical ventilation	through study completion, an average of 15 days	time of mechanical ventilation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Physical Education College; 🇧🇷 Petrolina, Pernambuco, Brazil