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

Assessment of the Effect of an Inspiratory Muscle Training Regimen on Decannulation Time in Adult Hospitalized Subjects with Tracheostomy Secondary to Prolonged Mechanical Ventilation

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06684392
Enrollment
56
Registered
2024-11-12
Start date
2023-11-01
Completion date
2025-11-01
Last updated
2024-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diaphragm Disease, Tracheostomy Complication

Keywords

tracheostomy, inspiratory muscle training, diaphragm dysfunction, diaphragm ultrasound

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.

Interventions

OTHERInspiratory muscle training

Subjects 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.

Sponsors

University of Chile
CollaboratorOTHER
Hospital Dr. Franco Ravera Zunino
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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 \[IC\]).

Design outcomes

Primary

MeasureTime frameDescription
Maximal inspiratory pressure2 weeksMaximum inspiratory pressure will be measured with the PowerBreathe valve before and after the training protocol to determine changes in diaphragm strength

Secondary

MeasureTime frameDescription
Diaphragm thickness2 weeksChanges in diaphragm thickness will be assessed via ultrasound before and after the training protocol.
Diaphragm excursion2 weeksChanges in diaphragm excursion will be assessed via ultrasound before and after the training protocol

Countries

Chile

Contacts

Primary ContactKinesióloga Jennifer Ayuso, Master of science
jenniferayuso@gmail.com+56966453201

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026