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Effectiveness Inspirational Muscle Training (IMTversusMV)

Primary Purpose

Respiratory Insufficiency

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Inspiratory Muscle Training (IMT)
Intensive Physiotherapy (IPT)
Sponsored by
Universidade Federal do vale do São Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Insufficiency focused on measuring Breathing Exercises, Respiratory Muscles, Respiration Artificial, Weaning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Physical Education CollegeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Inspiratory Muscle Training (IMT)

Intensive Physiotherapy (IPT)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Weaning mechanical ventilation
time of mechanical ventilation

Secondary Outcome Measures

length of stay in the ICU
reduction length of stay in the ICU
extubation success
extubation success after 48 hours
death
reduction in mortality (death)

Full Information

First Posted
November 21, 2018
Last Updated
May 9, 2023
Sponsor
Universidade Federal do vale do São Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT03758573
Brief Title
Effectiveness Inspirational Muscle Training
Acronym
IMTversusMV
Official Title
Effectiveness of Early Inspirational Muscle Training in Patients Submitted to Mechanical Ventilation: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do vale do São Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Insufficiency
Keywords
Breathing Exercises, Respiratory Muscles, Respiration Artificial, Weaning

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Inspiratory Muscle Training (IMT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Intensive Physiotherapy (IPT)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Inspiratory Muscle Training (IMT)
Intervention Description
Inspiratory Muscle Training (IMT)
Intervention Type
Other
Intervention Name(s)
Intensive Physiotherapy (IPT)
Intervention Description
Intensive Physiotherapy (IPT)
Primary Outcome Measure Information:
Title
Weaning mechanical ventilation
Description
time of mechanical ventilation
Time Frame
through study completion, an average of 15 days
Secondary Outcome Measure Information:
Title
length of stay in the ICU
Description
reduction length of stay in the ICU
Time Frame
through study completion, an average of 15 days
Title
extubation success
Description
extubation success after 48 hours
Time Frame
through study completion, an average of 2 days
Title
death
Description
reduction in mortality (death)
Time Frame
yes or not death, through study completion, an average of 15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rodrigo GS Carvalho, PhD
Phone
+5587999832015
Email
rodrigocarvalhofisio@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rodrigo GS Carvalho, PhD
Phone
+558721016856
Email
rodrigo.carvalho@univasf.edu.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodrigo GS Carvalho, PhD
Organizational Affiliation
Physical Education College / UNIVASF
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physical Education College
City
Petrolina
State/Province
Pernambuco
ZIP/Postal Code
56304917
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodrigo GS Carvalho, PhD
Phone
8721016856
Email
rodrigo.carvalho@univasf.edu.br
First Name & Middle Initial & Last Name & Degree
Rodrigo GS Carvalho, PhD
Phone
8721016856
Email
rodrigocarvalhofisio@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Registration ClinicalTrials; Study Protocol; Paper results.

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Effectiveness Inspirational Muscle Training

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