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Use of a New Isokinetic Device for Inspiratory Muscle Training

Primary Purpose

Respiration, Artificial

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Inspiratory muscle training
Sponsored by
Universidade Federal Fluminense
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Respiration, Artificial focused on measuring Mechanical Ventilator Weaning, Respiratory Muscle Training, Mortality Rate

Eligibility Criteria

18 Years - 86 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Hospital Naval Marcilio Dias

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

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

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

Outcomes

Primary Outcome Measures

Successful weaning
defined by 48 hours on spontaneous ventilation after ventilator withdrawal

Secondary Outcome Measures

Change in maximal inspiratory strength in cm H2O as measured by the digital manovacuometer MVD300 for 60 seconds
Assessment of inspiratory strength by the maximal inspiratory pressure and the timed inspiratory effort index
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
Assessment of inspiratory strength by the maximal inspiratory pressure and the timed inspiratory effort index
Time off the ventilator in the ICU in days.
Assessment of the time the patients are kept in the ICU after the successful weaning,

Full Information

First Posted
September 19, 2016
Last Updated
August 4, 2021
Sponsor
Universidade Federal Fluminense
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1. Study Identification

Unique Protocol Identification Number
NCT02932189
Brief Title
Use of a New Isokinetic Device for Inspiratory Muscle Training
Official Title
Use of a New Isokinetic Device Oriented by Software for Inspiratory Muscle Training in Prolonged Weaning
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
September 2020 (Actual)
Study Completion Date
September 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal Fluminense

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The control group only performed inspiratory muscle training (IMT) with the use of the T-piece. From the first day of prolonged weaning, patients would remain in spontaneous breathing progressing their stay time each day, respecting the criteria already mentioned for interruption and return to mechanical ventilation in support pressure mode. The intervention group, in addition to the protocol described above, would undergo inspiratory muscle training with the POWER breathe K-5 (UK) device. POWER breathe K-5 will be employed once a day, with an initial loading of 40% of maximal inspiratory strength in a schedule of 30 repetitions. This number of repetitions could be reached in one to 6 sessions depending on the respiratory muscle force of the patient. Most of the times more than one session were required. Typically, subjects performed two to six sessions of 5 to 15 breaths per day, with two minutes rest in ventilation pressure support mode. When the patient was unable to comply with the schedule, the training session was interrupted at a total of 3 minutes. The load was planned to be adjusted weekly with a 5 to 10% increase until 60% of the maximal inspiratory strength was reached with a total time of 10 minutes or 100 breaths. After training with POWER breathe K-5 (UK), the patient would return to mechanical ventilation in support pressure mode for 30-60 minutes, and then follow the conventional T-piece protocol. The IMT was conducted normally between 08h and 10h, Monday through Friday. All study subjects would be under continuous surveillance through the multi-parameter DX 2010 monitor (Dixtal, São Paulo, SP, Brazil), which records the electrocardiogram, heart rate, peripheral oxygen saturation and systemic arterial pressure. At any sign of instability, the IMT was interrupted and the patient returned to the ventilatory support and/or supplemental oxygen therapy for recovery. The trial was stopped if at least one of the following intolerance criteria was present: SaO2<90% or PaO2 <60 mm Hg with FIO2 >0.4; PaCO2 > 50 mm Hg or increased by > 8 mm Hg; arterial pH < 7.33 or decreased by 0.07 or more; breathing frequency > 35 breaths/min or increased by 50% for 5 min or longer; heart rate > 140 beats/min or a sustained increase or decrease of > 20%; mean blood pressure > 130 or < 70 mm Hg; or presence of agitation, diaphoresis, disorientation, or depressed mental status.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiration, Artificial
Keywords
Mechanical Ventilator Weaning, Respiratory Muscle Training, Mortality Rate

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Procedure: Ventilator weaning in the conventional way with a tracheal collar.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Procedure: Ventilator weaning with a tracheal collar after inspiratory muscle training with an isokinetic device. Device: K5 Power Breath
Intervention Type
Device
Intervention Name(s)
Inspiratory muscle training
Intervention Description
For the inspiratory muscle training, an isokinetic device (K5 Power Breath, United Kingdom) will be attached to the artificial airway.
Primary Outcome Measure Information:
Title
Successful weaning
Description
defined by 48 hours on spontaneous ventilation after ventilator withdrawal
Time Frame
one year
Secondary Outcome Measure Information:
Title
Change in maximal inspiratory strength in cm H2O as measured by the digital manovacuometer MVD300 for 60 seconds
Description
Assessment of inspiratory strength by the maximal inspiratory pressure and the timed inspiratory effort index
Time Frame
one year
Title
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
Description
Assessment of inspiratory strength by the maximal inspiratory pressure and the timed inspiratory effort index
Time Frame
one year
Title
Time off the ventilator in the ICU in days.
Description
Assessment of the time the patients are kept in the ICU after the successful weaning,
Time Frame
one year
Other Pre-specified Outcome Measures:
Title
Mortality rate
Description
mortality will be analysed for one year after entrance in the study.
Time Frame
two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
86 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Individuals over the age of 18 on mechanical ventilation Able to initiate ventilator weaning. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jocemir R Lugon, MD, PhD
Organizational Affiliation
Universidade Federal Fluminense
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Naval Marcilio Dias
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
20725-090
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33332819
Citation
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.
Results Reference
derived

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Use of a New Isokinetic Device for Inspiratory Muscle Training

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