Improving decannulation time in tracheostomized patients through inspiratory muscle training
Assessment of the Effect of an Inspiratory Muscle Training Regimen on Decannulation Time in Adult Hospitalized Subjects with Tracheostomy Secondary to Prolonged Mechanical Ventilation
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Dr. Franco Ravera Zunino Academic / other |
| Locations | 1 site (Rancagua, Región del Libertador General Bernardo O’Higgins) |
| Trial ID | NCT06684392 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with degenerative neuromuscular diseases or those who refuse to participate will not benefit from this study.
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 performed: While the concept of inspiratory muscle training is recognized, this specific individualized approach has not been widely tested, making it a novel intervention.
Eligibility criteria
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 this trial is running
Rancagua, Región del Libertador General Bernardo O’Higgins
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.