Improving decannulation time in tracheostomized patients through inspiratory muscle training
Official title: Assessment of the Effect of an Inspiratory Muscle Training Regimen on Decannulation Time in Adult Hospitalized Subjects with Tracheostomy Secondary to Prolonged Mechanical Ventilation
Run by Hospital Dr. Franco Ravera Zunino · NCT06684392 · Data updated 2026-11-12
This study is testing if a special breathing exercise program can help patients with tracheostomies get off their breathing tubes faster than those who only receive regular therapy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 56 (estimated) |
| Sponsor | Hospital Dr. Franco Ravera Zunino Academic / other |
| Locations | 1 site (Rancagua, Región del Libertador General Bernardo O’Higgins) |
| Status | Recruiting |
| Started | November 1, 2023 |
| Main results expected | May 1, 2025 |
| Study ends | November 1, 2025 |
| Registry record updated | November 12, 2024 |
| Trial ID | NCT06684392 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are critically ill adults aged 18 and older who are connected to mechanical ventilation and have undergone tracheostomy due to prolonged ventilation.
✕Probably not a fit
Patients with degenerative neuromuscular diseases or those who refuse to participate will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This project evaluates the impact of an individualized inspiratory muscle training regimen on decannulation time in patients with tracheostomy due to prolonged mechanical ventilation. Over a two-week period, participants will engage in strength and endurance exercises aimed at enhancing respiratory muscle performance. The study compares an experimental group receiving this training alongside standard physiotherapy to a control group receiving only standard physiotherapy. Key outcomes include decannulation time, ICU length of stay, hospital days, and quality of life scores, with the goal of optimizing management for tracheostomized patients.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the time patients remain on tracheostomy, improving their recovery and quality of life.
How similar studies have gone: While the concept of inspiratory muscle training is recognized, this specific individualized approach has not been widely tested, making it a novel intervention.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Critically ill patients aged ≥ 18 years * Connected to mechanical ventilation * Secondary tracheostomy due to prolonged mechanical ventilation * Glasgow Coma Scale (GCS) \> 11 points * Level of cooperation score (S5Q) \> 3 points Exclusion Criteria: * Limitation of therapeutic effort (LTE\*) * Pregnancy * Transfer to another center before completing the training (2 weeks) * Degenerative neuromuscular disease * Refusal to participate in this study (declining to provide informed consent \[IC\]).
Where it's running
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Hospital Regional Franco Ravera Zunino
Rancagua, Región del Libertador General Bernardo O’Higgins, Chile Recruiting
Study contacts
- Study coordinator: Kinesióloga Jennifer Ayuso, Master of science
- Email: jenniferayuso@gmail.com
- Phone: +56966453201
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.