Clinical trial NCT05303623: The Effect of Inspiratory Muscle Training on Diaphragmatic Function in Mechanically Ventilated Patients
Official title: Radiological and Cardiopulmonary Evaluation of the Effect of Inspiratory Muscle Training on Diaphragmatic Function in Mechanically Ventilated Patients in the Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intensive Care Unit Acquired Weakness
Keywords: mechanical ventilated patients
Inspiratory muscle training
Physiotherapy and rehabilitation
diaphragmatic issue doppler
Respiratory muscle thickness
Lead sponsor: Istanbul Demiroglu Bilim University
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment Randomized Healthy participants
Primary purpose: TREATMENT

Brief summary: In this study, the effect of inspiratory muscle training on diaphragmatic functions will be investigated radiologically in mechanically ventilated patients.

Detailed description: Many patients who receive treatment in intensive care need mechanical ventilation support. Invasive mechanical ventilation is an application used in critically ill patients to provide pulmonary gas exchange and to relieve the respiratory muscles. Mechanical ventilation and long- term bed rest induced extremity muscle weakness is a common condition in patients hospitalized in the intensive care unit. Acquired muscle weakness in intensive care is associated with poor prognosis and high mortality At the same time, mechanical ventilation can lead to the development of respiratory muscle dystrophy and atrophy.

Recently, a similar concern has arisen about the potential negative effects of mechanical ventilation on respiratory muscles. This condition is called ventilator-induced diaphragmatic dysfunction In patients with mechanical ventilation, dysfunction, muscle fiber type change and barotrauma are seen especially in the diaphragm, which is the primary inspiratory muscle. Diaphragmatic dysfunction may promote prolong of intubation, weaning difficulties and risk of increase reintubation in patients who are mechanically ventilated.

The effect of inspiratory muscle training, which is applied in addition to conventional respiratory physiotherapy, on diaphragmatic dysfunction, on the weaning process and the long of stay in intensive care has not been fully elucidated, and a limited number of studies have been conducted on this subject It has been reported that in patients with prolonged mechanical ventilation, diaphragmatic peak contraction velocity, peak relaxation velocity, movement speed, velocity time integral are lower than healthy individuals and this is correlated with failure to wean from mechanical ventilation. We could not find any report and clinical trial in the literature evaluation the effect of conventional physiotherapy and additional inspiratory muscle training on diaphragmatic tissue movement velocity and diaphragm thickness using detailed radiological methods in intensive care patients dependent on mechanical ventilation. In this context, our not working has a unique value. Our study will contribute to elucidating the mechanisms that affect the weaning process from mechanical ventilation in intensive care patients. It is aimed to develop strategies that will shorten the long of stay in intensive care and total hospital stay with therapeutic approaches that enable patients to be extubated as early as possible.

Eligibility criteria: For Patients Group Inclusion Criteria:

* Needing mechanical ventilation support longer than 2 days,
* Alert and Riker Sedation Agitation Score \>4
* Being hemodynamically stable (HR\<140 beats/min, BP stable)
* Dobutamine and minimal vasopressor use
* Fever of 36.5-38.5
* Body Mass Index \<40 m2/cm,
* FiO2 of 0.5 or less,
* Absence of myocardial ischemia.

For Patients Group Exclusion Criteria:

* Noncooperation
* Phrenic nerve damage
* Chest wall trauma and/or deformity to prevent diaphragmatic movement
* Progressive neuromuscular disease with respiratory involvement
* There is enough secretion to require more than one aspiration every hour.
* Patients using sedative drugs continuously
* High-dose cortisol use
* Using a home mechanical ventilator before mechanical ventilation in intensive care unit

For Healthy Group Inclusion Criteria:

* With the control and intervention group, age, characteristics and characteristics,
* Chronic system and no ongoing treatment,
* Body mass index not 40 kg/m2,
* 18-80 years old

Primary outcomes:
measure: Maximal inspiratory and expiratory pressure
timeFrame: Change from baseline Maximal inspiratory and expiratory pressure at 5th day
measure: Diaphragmatic B mode, M mode and Tissue Doppler Ultrasonographic Imagining
timeFrame: Change from baseline diaphragmatic evaluation at 5th day
measure: Respiratory Muscle Thickness
timeFrame: Change from baseline Respiratory Muscle Ultrasonographic Imagining evaluation at 5th day
measure: Physical Function Test (PFIT) battery
timeFrame: Change from baseline Physical Function Test (PFIT) battery 5th day
measure: Medical Research Council(MRC) Strength Test
timeFrame: Change from baseline Medical Research Council(MRC) Strength Test battery 5th day
measure: Acute Care Index of Function (ACIF)
timeFrame: Change from baseline Acute Care Index of Function (ACIF) 5th day
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Demiroglu University
Study officials:
affiliation: Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital
name: Barış Yılmaz, Specialist
role: STUDY_CHAIR
References: