Effectiveness Inspirational Muscle Training

Respiratory Insufficiency Clinical Trial

— IMTversusMV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03758573
• Other study ID #: IMT
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2023
• Source: Universidade Federal do vale do São Francisco
• Contact: Rodrigo GS Carvalho, PhD
• Phone: +5587999832015
• Email: rodrigocarvalhofisio[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Insufficiency

Intervention

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

Locations

Country	Name	City	State
Brazil	Physical Education College	Petrolina	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do vale do São Francisco

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weaning mechanical ventilation	time of mechanical ventilation	through study completion, an average of 15 days
Secondary	length of stay in the ICU	reduction length of stay in the ICU	through study completion, an average of 15 days
Secondary	extubation success	extubation success after 48 hours	through study completion, an average of 2 days
Secondary	death	reduction in mortality (death)	yes or not death, through study completion, an average of 15 days