Clinical trial Recruiting at 1 site Interventional Ages 18 and up

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 typeInterventional
Ages18 Years and up
SexAll
Enrollment56 (estimated)
SponsorHospital Dr. Franco Ravera Zunino
Academic / other
Locations1 site (Rancagua, Región del Libertador General Bernardo O’Higgins)
StatusRecruiting
StartedNovember 1, 2023
Main results expectedMay 1, 2025
Study endsNovember 1, 2025
Registry record updatedNovember 12, 2024
Trial IDNCT06684392 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

  • Hospital Regional Franco Ravera Zunino
    Rancagua, Región del Libertador General Bernardo O’Higgins, Chile
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.