Clinical trial NCT06684392: Assessment of the Effect of an Inspiratory Muscle Training Regimen on Decannulation Time in Tracheostomized Subjects
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tracheostomy Complication
Diaphragm Disease
Keywords: tracheostomy
inspiratory muscle training
diaphragm dysfunction
diaphragm ultrasound
Lead sponsor: Hospital Dr. Franco Ravera Zunino
Sponsor class: OTHER
Collaborators: name: University of Chile
First posted: 2024-11-12
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Control Group (CG): The CG will follow the current protocol at HRLBO. This involves a weaning protocol from mechanical ventilation 24 hours after tracheostomy placement. Initial disconnection windows are 2 hours in the morning and 2 hours in the afternoon. If tolerated, the next day's windows extend to 4 hours each, and by the third day, to 6 hours. On the fourth day, a continuous 12-hour disconnection is attempted, progressing to 24 if successful. Additionally, subjects will train at 50% of their MIP in 5 sets of 6 breaths once weaned.

Intervention Group (IG): The IG will follow the CG protocol plus inspiratory muscle training (IMT). If weaning or disconnection is not achieved, subjects will train for inspiratory strength alone. Once weaning or disconnection is successful, the new IMT protocol combining strength and endurance training will begin. If the patient shows clinical signs of respiratory failure, IMT will be paused for the day.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Mechanical ventilation is a life-support intervention crucial for saving lives in ICU patients. However, its prolonged use leads to deterioration in respiratory muscle strength and endurance, causing diaphragm dysfunction. This weakening is associated with prolonged mechanical ventilation and increased difficulty in weaning the patient from the ventilator, known as "difficult weaning." It has been reported that up to 20% of ICU patients require tracheostomy due to this issue. Tracheostomy is an invasive procedure that involves creating an ostomy in the trachea to establish an artificial airway, allowing for ventilation, facilitating weaning from mechanical ventilation, and improving secretion management. However, muscle dysfunction from disuse and lack of effective respiratory muscle training extends the tracheostomy duration, leading to hospital-acquired infections, swallowing disorders, and increased ICU and hospital days. Thus, respiratory muscle training is a key tool for enabling tracheostomy removal (decannulation) and improving respiratory system efficiency. Since no universally accepted training protocol exists, it is not a common practice in ICUs worldwide, including our country. This project proposes that applying an individualized inspiratory muscle training regimen combining strength and endurance exercises for two weeks could improve respiratory muscle performance, reducing decannulation time (days from tracheostomy placement to removal).

The objective of this project is to assess the effect of an individualized inspiratory muscle training regimen, combining strength and endurance exercises for two weeks, 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 evaluated: an experimental group undergoing individualized inspiratory muscle training for 14 days plus standard physiotherapy, and a control group receiving standard physiotherapy and weaning guided by scheduled mechanical ventilation disconnection windows. Both groups will be compared in terms of decannulation time, ICU length of stay, hospital days, and quality of life survey scores. The study results will optimize the management of tracheostomized patients locally and nationally, reducing economic costs for both the country and patients and improving their quality of life, thus aiding in meeting some health objectives for the 2011-2020 decade.

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 \[IC\]).

Primary outcomes:
measure: Maximal inspiratory pressure
timeFrame: 2 weeks
Secondary outcomes:
measure: Diaphragm thickness
timeFrame: 2 weeks
measure: Diaphragm excursion
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Rancagua
country: Chile
facility: Hospital Regional Franco Ravera Zunino
state: O'Higgins
Study officials:
References: