Clinical trial NCT06251791: Inspiratory Muscle Training and Expiratory Muscle Thickness
Official title: Exploring The Impact Of Inspiratory Muscle Training on Expiratory Muscle Thickness During Intensive Care Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intensive Care Unit Syndrome
Muscle Weakness
Rehabilitation
Lead sponsor: Istanbul Demiroglu Bilim University
Sponsor class: OTHER
First posted: 2024-02-09
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 Parallel Assignment Randomized Healthy participants
Primary purpose: TREATMENT

Brief summary: the specific effect of IMT on expiratory muscle strength and abdominal wall thickness during weaning remains unclear. To address this significant research gap, the primary objective of our study was to evaluate the effect of IMT after extubation on expiratory muscle strength and abdominal muscle thickness in respiratory ICU patients. On the other hand the investigators established reference values for ultrasonographic measurements in healthy control subjects as a comparative arm. To the best of our knowledge, this is the first study to examine the ultrasonographic effects of IMT on the expiratory muscle thickness after extubation. The investigators believe that our study may contribute to related literature in this context and guide future research as a pioneer with its unique value.

Detailed description: the specific effect of IMT on expiratory muscle strength and abdominal wall thickness during weaning remains unclear. To address this significant research gap, the primary objective of our study was to evaluate the effect of IMT after extubation on expiratory muscle strength and abdominal muscle thickness in respiratory ICU patients. On the other hand the investigators established reference values for ultrasonographic measurements in healthy control subjects as a comparative arm. To the best of our knowledge, this is the first study to examine the ultrasonographic effects of IMT on the expiratory muscle thickness after extubation. The investigators believe that our study may contribute to related literature in this context and guide future research as a pioneer with its unique value. In this single-blind randomized controlled study, 20 patients were divided into two groups: IMT and conventional physiotherapy(CP). In order to establish normative data for abdominal muscle thickness, ten healthy controls were included in the study. The CP group received CP and the IMT group received CP+IMT for five days following extubation. The thicknesses of the external oblique abdominal(EOA),internal oblique sbdominal(IOA), transversus abdominus (TRA) and rectus abdominis (RA) muscleswere evaluated The maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) were recorded.

Eligibility criteria: Inclusion 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.

Exclusion Criteria:

* 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: Abdominal Muscle Thickness
timeFrame: Change from baseline Maximal inspiratory and expiratory pressure at 5th day]
Secondary outcomes:
measure: Maximal inspiratory and expiratory pressure
timeFrame: Change from baseline Maximal inspiratory and expiratory pressure at 5th day]
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Demiroglu University
state: Şişli
Study officials:
affiliation: Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital
name: barış yılmaz, MD
role: STUDY_CHAIR
References: