Use of a New Isokinetic Device for Inspiratory Muscle Training

NCT02932189 | Completed

• 1 other identifier: isokinetic device
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: It is well established that physical fitness improves muscle performance either in sedentary people or in athletes. In this regard, specific exercises for respiratory muscles can result in better functional performance in hospitalized individuals, especially in critically ill patients in prolonged weaning. Objectives: To compare the following variables between intervention and control patients: success in weaning, free time off ventilator on ICU after weaning, and gain of muscle strength with the use of the inspiratory muscle training (IMT). Patients and methods: Prospective randomized controlled clinical trial. Only individuals on prolonged weaning will be enrolled. They will undergo IMT or will be managed in a conventional manner. The primary endpoint will be successful weaning. In addition, other variables such as free time off ventilator on ICU after weaning and muscle strength will be measured. In addition, mortality in the ICU, inside the hospital and after discharge will be followed for one year after study entrance. Expected results: According to the working hypothesis, it is expected that the performance of patients undergoing IMT will be superior to the conventional treatment. Also, their time to mortality is expected to be longer.

Conditions

Respiration, Artificial

Keywords

Mechanical Ventilator Weaning; Respiratory Muscle Training; Mortality Rate

Outcome Measures

Primary Outcomes (1)

• Successful weaning

  defined by 48 hours on spontaneous ventilation after ventilator withdrawal

  one year

Secondary Outcomes (3)

• Change in maximal inspiratory strength in cm H2O as measured by the digital manovacuometer MVD300 for 60 seconds

  one year

• Change in the timed inspiratory effort index in cm H2O/sec as calculated by the ratio of the maximal inspiratory pressure and time demanded to reach it as measured by the digital manovacuometer MVD300 for 60 seconds

  one year

• Time off the ventilator in the ICU in days.

  one year

Other Outcomes (1)

• Mortality rate

  two years

Study Arms (2)

Control

NO INTERVENTION

Procedure: Ventilator weaning in the conventional way with a tracheal collar.

Intervention

EXPERIMENTAL

Procedure: Ventilator weaning with a tracheal collar after inspiratory muscle training with an isokinetic device. Device: K5 Power Breath

Device: Inspiratory muscle training

Interventions

Inspiratory muscle training DEVICE

For the inspiratory muscle training, an isokinetic device (K5 Power Breath, United Kingdom) will be attached to the artificial airway.

Intervention

Eligibility Criteria

• Age: 18 Years - 86 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals over the age of 18 on mechanical ventilation
• Able to initiate ventilator weaning.

You may not qualify if:

• Positive serology for HIV
• Other immunesupressive conditions
• Life expectancy less than 12 months
• Spinal cord injury above T8
• Mechanical ventilation started at another institution
• Body mass index \>35 kg/m2.

Sponsors & Collaborators

• Universidade Federal Fluminense: lead

Study Sites (1)

Hospital Naval Marcilio Dias

Rio de Janeiro, Rio de Janeiro, 20725-090, Brazil

Location

Related Publications (1)

• da Silva Guimaraes B, de Souza LC, Cordeiro HF, Regis TL, Leite CA, Puga FP, Alvim SH, Lugon JR. Inspiratory Muscle Training With an Electronic Resistive Loading Device Improves Prolonged Weaning Outcomes in a Randomized Controlled Trial. Crit Care Med. 2021 Apr 1;49(4):589-597. doi: 10.1097/CCM.0000000000004787.

  PMID: 33332819 DERIVED

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jocemir R Lugon, MD, PhD

  Universidade Federal Fluminense

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 19, 2016
• First Posted: October 13, 2016
• Study Start: January 1, 2016
• Primary Completion: September 1, 2020
• Study Completion: September 15, 2020
• Last Updated: August 5, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)