Clinical trial NCT06611683: Effect of Inspiratory Muscle Training on Ventilated Patients in an Intensive Care Unit
Official title: Effect of Inspiratory Muscle Training on Ventilated Patients in an Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critically Ill, Subacute Adult Patients
Mechanically Ventilation
Keywords: sub-acute critical ill
mechanical ventilation
respiratory muscle training
respiratory muscle strength
rapid shallow breathing index
Lead sponsor: Chang Gung University
Sponsor class: OTHER
Collaborators: name: Zuoying Armed Forces General Hospital
name: Kaohsiung Chang Gung Memorial Hospital,Taiwan
First posted: 2024-09-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if inspiratory muscle training facilite the liberation of mechanical ventilation. The main questions it aims to answer are:

Does inspiratory muscle training facilitate weaning from mechanical ventilation and enhance muscle strength in critically ill, subacute adult patients?

The main questions it aims to answer are:

Does pulmonary rehabilitation facilitate wwaning form mechanical patients? Does the intervention improve respiratory muscle strength and respiratory patterns?

Participants received:

Inspriatory muscle training twice daily for three consecutive weeks or until the subject no longer required ventilator support.

Detailed description: Patients on mechanical ventilation often experience rapid diaphragm atrophy on the second day, resulting in muscle fiber changes, respiratory muscle weakness. Clinical studies have explored enhancing diaphragm and respiratory muscle strength and endurance through inspiratory muscle, expiratory muscle, and combined respiratory muscle training. This study was to determine if inspiratory muscle training significantly facilitates liberation from mechanical ventilation and improves muscle strength when compared to without IMT among subacute critically ill adult patients.

Eligibility criteria: Inclusion Criteria:

* requiring invasive mechanical ventilation for 2 days in an ICU

Exclusion Criteria:

* hemodynamic instability (heart rate 120 beats/min, unstable blood pressure, vasopressor infusion)
* inadequate oxygenation (PEEP 8 cmH2O, FiO2 50%)
* body temperature 38.5°C
* sepsis
* use of sedative infusion
* steroid administration
* home ventilator use before ICU admission

Primary outcomes:
measure: Number of days until liberation from mechanical ventilation
timeFrame: Three weeks
Secondary outcomes:
measure: Maximum inspiratory pressure
timeFrame: Three weeks
measure: Maximum expiratory pressure
timeFrame: Three weeks
measure: Peak expiratory flow
timeFrame: Three weeks
measure: Peak inspiratory flow
timeFrame: Three weeks
measure: Rapid Shallow breathing index
timeFrame: Three weeks
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Zuoying Armed Forces General Hospital
Study officials:
affiliation: Zuoying Armed Forces General Hospital
name: Shu-Jane Wang, MS
role: STUDY_DIRECTOR
References: