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

Recruiting now · Not applicable

Conditions studied: Tracheostomy Complication, Diaphragm Disease

In brief

The objective of this project is to evaluate the effect of applying an individualized inspiratory muscle training regimen, combining strength and endurance exercises over a two-week period, on improving maximum inspiratory pressure, diaphragm thickness fraction, and its impact on successful decannulation time in patients with tracheostomy secondary to prolonged mechanical ventilation at HRLBO. Two groups of adult tracheostomized patients will be assessed: an experimental group, who will follow an individualized inspiratory muscle training regimen for 14 days along with standard physiotherapy, and a control group, who will receive standard physiotherapy and guided weaning through scheduled disconnection windows from mechanical ventilation. Both groups will be compared in terms of decannulation time, ICU length of stay, hospital days, and quality of life survey scores. The results of this study will help optimize the management of tracheostomized patients locally and nationally, reducing economic costs for both the country and the patients, and improving their quality of life, contributing to some health objectives for the 2011-2020 decade.

Key facts

Study ID

NCT06684392

Run by

Hospital Dr. Franco Ravera Zunino

People needed

56

Starts

2023-11-01

Expected to finish

2025-11-01

Last updated by the study team

2024-11-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Hospital Regional Franco Ravera Zunino — Rancagua, Región del Libertador General Bernardo O’Higgins, Chile (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.