Actively Recruiting
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
Eligibility Criteria
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
You will not qualify if you...
- Terminal condition or receiving palliative care
- Neuromuscular or neurological conditions prior to ICU admission
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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
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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