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Effectiveness Inspirational Muscle Training

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03758573
Acronym
IMTversusMV
Enrollment
40
Registered
2018-11-29
Start date
2019-01-15
Completion date
2023-12-31
Last updated
2023-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Insufficiency

Keywords

Breathing Exercises, Respiratory Muscles, Respiration Artificial, Weaning

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).

Interventions

OTHERInspiratory Muscle Training (IMT)

Inspiratory Muscle Training (IMT)

OTHERIntensive Physiotherapy (IPT)

Intensive Physiotherapy (IPT)

Sponsors

Universidade Federal do vale do São Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Weaning mechanical ventilationthrough study completion, an average of 15 daystime of mechanical ventilation

Secondary

MeasureTime frameDescription
length of stay in the ICUthrough study completion, an average of 15 daysreduction length of stay in the ICU
extubation successthrough study completion, an average of 2 daysextubation success after 48 hours
deathyes or not death, through study completion, an average of 15 daysreduction in mortality (death)

Countries

Brazil

Contacts

Primary ContactRodrigo GS Carvalho, PhD
rodrigocarvalhofisio@gmail.com+5587999832015
Backup ContactRodrigo GS Carvalho, PhD
rodrigo.carvalho@univasf.edu.br+558721016856

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026