Can High Intensity Inspiratory Muscle Training Improve Inspiratory Muscle Strength and Accelerate Weaning in Medical Patients With Difficulty on Weaning?

April 16, 2021 updated by: Hospital Universitari Vall d'Hebron Research Institute

Can High Intensity Inspiratory Muscle Training Improve Inspiratory Muscle Strength and Accelerate Weaning in Medical Patients With Difficulty on Weaning Admitted in the Intensive Care Unit?

Introduction: It has been described that invasive mechanical ventilation leads to diaphragm weakness. The inspiratory muscle weakness is related with a difficult and prolonged weaning as well as longer duration of mechanical ventilation and increased risk of complications and death. Consequently, the duration of stay in ICU is longer and the costs in ICU increase.

Objectives: To determine the effects of a high intensity inspiratory muscle training (IMT) on inspiratory muscle strength, weaning outcomes, complications and length of stay in the ICU in medical patients with difficulty on weaning and admitted in the ICU.

Methodology: In a single blind randomized clinical trial, 40 tracheotomy ventilated medical patients in which spontaneous breathing trial has failed ≥ 1 time, will be selected and randomized into two equitable groups. In the intervention group, IMT will be performed at 60% of the maximum inspiratory pressure (which will increase by 10% every week) while in the control group it will be performed at 30%. In both groups, 5 sets of 6 breaths will be performed, once a day, 5 days a week, for a maximum of 28 days or until the patient is successfully weaned. The main outcome will be the maximum inspiratory pressure, while the maximum expiratory pressure, weaning duration process, weaning success, duration of mechanical ventilation, length of stay in the ICU, complications and the rapid shallow breathing index will be analyzed as secondary outcomes.

t-student test for independent samples will be used to analyze quantitative outcomes. For qualitative outcomes will be used X2 test. A value of p<0.05 will be assumed as an indicator of statistically significant results.

Future contributions: Our collect results can be useful for the updating of the clinical practice guidelines and promote its implementation in the clinical practice.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
        • Contact:
          • Bernat Planas Pascual, MSc
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron Research Institute
        • Contact:
        • Contact:
        • Principal Investigator:
          • Bernat Planas Pascual, PT,MSc
        • Sub-Investigator:
          • Alba Gomez Garrido, MD, PhD
        • Sub-Investigator:
          • Esther Batlle Borraz, PT
        • Sub-Investigator:
          • Alberto Rojo Ruiz, PT
        • Sub-Investigator:
          • Gonzalo Ballesteros Reviriego, PT, MSc

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 to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Medical patients aged ≥ 18 years hospitalized in the ICU.
  • Patients ventilated by tracheostomy and who have failed ≥ 1 spontaneous breathing test.
  • Being ventilated in assisted-controlled, assisted or pressure support modes.
  • PEEP ≤ 10 cmH2O
  • Richmond Agitation-Sedation Scale between -1 and 0.
  • Confusion Assessment Method for the Intensive Care Unit negative.
  • Cardiorespiratory and hemodynamic stability in the absence of vasopressor support or with minimal requirement (dobutamine or dopamine ≤ 5 μg / kg / min, phenylephrine ≤ 1 μg / kg / min).
  • FiO2 ≤ 0,6
  • PaO2/FiO2 ratio > 200
  • Blood lactate levels < 4 mmol/L

Exclusion Criteria:

  • Progressive neuromuscular disease
  • Thoraco-abdominal surgery in a period <30 days from the beginning of the study.
  • Diseases that cause hemodynamic instability (cardiac arrhythmia, decompensated heart failure, unstable ischemic heart disease).
  • Hemoptysis
  • Unstable chest wall.
  • Not drained pneumothorax
  • Phrenic nerve injury
  • Spinal cord injury above T8
  • Clinical signs of respiratory distress (paradoxal breathing, use of accessory respiratory muscles)
  • Body mass index > 40 kg / m2
  • Use domiciliary ventilator support prior to hospitalization.
  • Skeletal disorder of the rib cage that impairs its biomechanics (severe kyphoscoliosis, congenital deformities).
  • Body temperature > 38ºC
  • Pregnancy
  • Receive therapy with nitric oxide or nebulized prostacyclin.
  • Medical order.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Low Intensity IMT
Procedure: Low Intensity IMT

The control group will get a supervised IMT with Threshold IMT device, once a day, 5 days a week for a maximum of 28 days or until the participant is weaned successfully. In each session the participant will do 5 sets of 6 repetitions with 2 minutes of rest between sets. The initial training load will be adjusted to 30% of the MIP and will be increased by 10% of the initial MIP weekly.

The patient will be placed in a semi-incorporated position (head of the bed elevated 45º). The ICU physiotherapist will check before training that the cuff of the tracheal tube is correctly swollen to avoid air leaks during the training. The ICU physiotherapist will disconnect the mechanical ventilation during the IMT and will provide supplemental oxygen when required. However, between series the participant will be returned to ventilator support. Patients will be instructed to do a whole expiration and immediately inspire as forceful as possible until reaching the total lung capacity.
Experimental: High Intensity IMT
Procedure: High Intensity IMT

The experimental group will get a supervised IMT with Threshold IMT device, once a day, 5 days a week for a maximum of 28 days or until the participant is weaned successfully. In each session the participant will do 5 sets of 6 repetitions with 2 minutes of rest between sets. The initial training load will be adjusted to 60% of the MIP and will be increased by 10% of the initial MIP weekly.

The patient will be placed in a semi-incorporated position (head of the bed elevated 45º). The ICU physiotherapist will check before training that the cuff of the tracheal tube is correctly swollen to avoid air leaks during the training. The ICU physiotherapist will disconnect the mechanical ventilation during the IMT and will provide supplemental oxygen when required. However, between series the participant will be returned to ventilator support. Patients will be instructed to do a whole expiration and immediately inspire as forceful as possible until reaching the total lung capacity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inspiratory muscle strength
Time Frame: Through study completion, an average of 28 days

Measured with MIP (Maximal Inspiratory Pressure)

Assessments:

Baseline, after the intervention period
Through study completion, an average of 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Expiratory muscle strength
Time Frame: Through study completion, an average of 28 days

Measured with MEP (Maximal Expiratory Pressure)

Baseline, after the intervention period
Through study completion, an average of 28 days
Rapid Shallow Breathing Index
Time Frame: Through study completion, an average of 28 days
Measured with the mechanical ventilator
Through study completion, an average of 28 days
Duration of the weaning period
Time Frame: Through study completion, an average of 28 days
Defined as the hours since the first attempt of spontaneous breathing (or the initiation of pressure support ≤ 7 cmH2O) to successful weaning
Through study completion, an average of 28 days
Weaning success
Time Frame: Through study completion, an average of 28 days
Recorded as successfully if the patient can breathe spontaneously through tracheostomy without restart mechanical ventilation for at least 48 hours.
Through study completion, an average of 28 days
Duration of mechanical ventilation
Time Frame: Through study completion, an average of 28 days
Recorded as the days since patient was connected to mechanical ventilator to successful weaning.
Through study completion, an average of 28 days
Length of stay in the ICU
Time Frame: Through study completion, an average of 28 days
Measured in days.
Through study completion, an average of 28 days
Complications
Time Frame: Through study completion, an average of 28 days
Defined as the patient needs to be intubated again when the patient was weaned or the death of the participant
Through study completion, an average of 28 days

Collaborators and Investigators

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

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Investigators

  • Principal Investigator: Bernat Planas Pascual, PT,MSc, Hospital Universitari Vall d'Hebron Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

June 1, 2021

Primary Completion (Anticipated)

September 15, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

April 9, 2020

First Submitted That Met QC Criteria

April 11, 2020

First Posted (Actual)

April 15, 2020

Study Record Updates

Last Update Posted (Actual)

April 19, 2021

Last Update Submitted That Met QC Criteria

April 16, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR(ATR)03/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

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