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Search / Trial NCT06684392

Assessment of the Effect of an Inspiratory Muscle Training Regimen on Decannulation Time in Tracheostomized Subjects

Launched by HOSPITAL DR. FRANCO RAVERA ZUNINO · Nov 11, 2024

Trial Information

Current as of July 26, 2025

Recruiting

Keywords

Tracheostomy Inspiratory Muscle Training Diaphragm Dysfunction Diaphragm Ultrasound

ClinConnect Summary

This clinical trial is studying the effects of a special breathing exercise program on patients who have had a tracheostomy, which is a procedure that helps people breathe when they have been on a ventilator for a long time. The goal is to see if these exercises can help patients get off the ventilator and remove the tracheostomy tube faster, improving their overall breathing strength and quality of life. Participants will be divided into two groups: one group will do the breathing exercises along with their usual therapy, while the other group will just receive standard therapy. Researchers will compare how quickly each group can have their tracheostomy tube removed and how long they stay in the hospital.

To be eligible for this trial, participants should be adults aged 18 or older who are currently on a ventilator and have had a tracheostomy because of long-term ventilation. They should also be able to cooperate with the therapy. However, people with certain conditions, like severe neuromuscular diseases or those who are pregnant, cannot join the study. By participating, patients may help improve treatment strategies for others in similar situations, and the findings could lead to better care and cost savings in the healthcare system.

Gender

ALL

Eligibility 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 \[IC\]).

About Hospital Dr. Franco Ravera Zunino

Hospital Dr. Franco Ravera Zunino is a leading healthcare institution dedicated to advancing medical research and improving patient outcomes through innovative clinical trials. With a commitment to excellence in patient care and a focus on evidence-based practices, the hospital serves as a collaborative partner in the clinical research community. It aims to foster cutting-edge studies across various therapeutic areas, ensuring the highest ethical standards and adherence to regulatory guidelines. The institution is equipped with state-of-the-art facilities and a team of experienced professionals, making it an ideal setting for conducting impactful clinical research that contributes to the broader medical field.

Locations

Rancagua, O'higgins, Chile

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported