Effectiveness Inspirational Muscle Training (IMTversusMV)

May 9, 2023 updated by: Rodrigo Gustavo da Silva Carvalho, Universidade Federal do vale do São Francisco

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Inspiratory Muscle Training (IMT)
IMT by means of the Powerbreath equipment (Classic, London, UK), according to the following parameters: initial loading of 40% of MIP, 3 sets of 10 repetitions with interval of 1 minute between each sets, 7 days a week, 2 times a day , with the patients in the bed with the angulation of 45 °. The IMT load settings will be adjusted according to the values evaluated weekly. If there is need for addition of supplemental oxygen will be performed to perform the IMT.
Other: Inspiratory Muscle Training (IMT)
Inspiratory Muscle Training (IMT)
Active Comparator: Intensive Physiotherapy (IPT)
IPT will be to individualized and supervised intervention program consisting of any of the following procedures: passive, assisted, active or resisted mobilization, sedation and orthostasis depending on the functional level of the patient, as well as bronchial hygiene therapy and pulmonary expansion therapy.
Other: Intensive Physiotherapy (IPT)
Intensive Physiotherapy (IPT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weaning mechanical ventilation
Time Frame: through study completion, an average of 15 days
time of mechanical ventilation
through study completion, an average of 15 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal do vale do São Francisco

Investigators

  • Principal Investigator: Rodrigo GS Carvalho, PhD, Physical Education College / UNIVASF

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2019

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

November 21, 2018

First Submitted That Met QC Criteria

November 27, 2018

First Posted (Actual)

November 29, 2018

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Registration ClinicalTrials; Study Protocol; Paper results.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Respiratory Insufficiency

Clinical Trials on Inspiratory Muscle Training (IMT)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kazakhstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe