About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Critically ill patients aged ≥ 18 years
Connected to mechanical ventilation
Secondary tracheostomy due to prolonged mechanical ventilation
Glasgow Coma Scale (GCS) > 11 points
Disqualifiers
Limitation of therapeutic effort (LTE*)
Pregnancy
Transfer to another center before completing the training (2 weeks)
Degenerative neuromuscular disease
Trial design
Parallel
Treatments tested in this trial
Inspiratory muscle training
Other interventionSubjects will train only inspiratory muscle strength if they do not achieve VP or definitive disconnection of MV, and, when they already achieve these VP or definitive disconnection, the new EMI regimen that combines strength and resistance training will begin to be applied. Inspiratory muscle training guideline (EMI). On the day that, according to the EMI guideline, the Pimax evaluation corresponds, the training time will be replaced by the evaluation to avoid overloading the subjects with ventilatory work, training them only once a day.
Treatment groups
Trial outcomes
Primary outcomes
Maximal inspiratory pressure
Maximum inspiratory pressure will be measured with the PowerBreathe valve before and after the training protocol to determine changes in diaphragm strength
Secondary outcomes
Diaphragm thickness
Changes in diaphragm thickness will be assessed via ultrasound before and after the training protocol.
Diaphragm excursion
Changes in diaphragm excursion will be assessed via ultrasound before and after the training protocol
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Hospital Dr. Franco Ravera Zunino
Lead sponsor
University of Chile
Collaborator