Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07613021

Effectiveness of Inspiratory Muscle Training in Weaning ICU Patients

Led by University of West Attica · Updated on 2026-05-29

45

Participants Needed

2

Research Sites

26 weeks

Total Duration

On this page

Sponsors

U

University of West Attica

Lead Sponsor

G

General Hospital of Chalkida

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of inspiratory muscle training (IMT) in helping patients in critical condition who have been on mechanical ventilation (MV) for at least 72 hours. These patients often develop muscle weakness, including diaphragm atrophy, which can make it harder to stop mechanical ventilation and may lead to longer ICU and hospital stays, as well as higher risks of infection and mortality. This study aims to see if using IMT can improve the success of weaning patients off MV and reduce their time in the ICU and hospital. The study compares two groups of ICU patients: one receiving an inspiratory muscle training program using an electronic breathing trainer, starting at 40% of their maximal inspiratory pressure (MIP) and increasing daily by 10%, with 30 repetitions split into sets, along with a protocolized early mobilization program; the other group receives only the early mobilization program. The IMT is applied daily for 5 days a week until ICU discharge. This is a randomized controlled trial with double masking to assess the effects of these interventions. Participants will be monitored for weaning success immediately after the intervention and other outcomes including duration of mechanical ventilation, MIP, maximal expiratory pressure (MEP), and length of ICU and hospital stay. Assessments of MIP and MEP are done at baseline and after the intervention. The study is sponsored by the University of West Attica and plans to follow patients until discharge from ICU, aiming to provide insights into improving care and reducing costs for ICU patients on mechanical ventilation.

CONDITIONS

Brief Title

Effectiveness of Inspiratory Muscle Training in Weaning ICU Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • On invasive mechanical ventilation for at least 72 hours
  • Adequate cooperativeness as assessed by 5SQ with a score of 3 or higher
Not Eligible

You will not qualify if you...

  • Terminal condition or receiving palliative care
  • Neuromuscular or neurological conditions prior to ICU admission

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Until ICU discharge

Participants receive inspiratory muscle training once a day, 5 days per week, along with a protocolized early mobilization program until ICU discharge.

Daily visits 5 days per week

Trial Site Locations

Total: 2 locations

1

General Hospital

Chalcis, Greece

Actively Recruiting

2

General Hospital "Agios Panteleimon"

Nikaia, Greece

Actively Recruiting

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Research Team

I

IRINI PATSAKI, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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