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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06251791
Other study ID # IMT on abdominal muscle
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2021
Est. completion date November 1, 2023

Study information

Verified date February 2024
Source Istanbul Demiroglu Bilim University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date November 1, 2023
Est. primary completion date December 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Intervention

Other:
conventional physiotherapy+ IMT
Conventional Physiotherapy to contain breathing and thoracal expansion exercises, bronchial hygiene techniques and gradual mobilization in 1 time a day. Conventional Physiotherapy to contain breathing and thoracal expansion exercises, bronchial hygiene techniques and gradual mobilization in 1 time a day. In this group addition to conventional physiotherapy inspiratory muscle training will be performed with the threshold-loaded inspiratory muscle training device, starting at 30% of the maximum inspiratory mouth pressure value, during 5 days, in 2 sessions, 4 sets per day, 6-8 breaths in each set and 2 minutes of rest between sets.
conventional physiotherapy
Conventional Physiotherapy to contain breathing and thoracal expansion exercises, bronchial hygiene techniques and gradual mobilization in 1 time a day. Conventional Physiotherapy to contain breathing and thoracal expansion exercises, bronchial hygiene techniques and gradual mobilization in 1 time a day.

Locations

Country Name City State
Turkey Istanbul Demiroglu University Istanbul Sisli

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Demiroglu Bilim University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Abdominal Muscle Thickness Eksternal Oblique, Internal Oblique, Transverses Abdominus and rectus abdominus Ultrasonografic mesasurements Change from baseline Maximal inspiratory and expiratory pressure at 5th day]
Secondary Maximal inspiratory and expiratory pressure Intraoral pressures measured at maximal respiration against a valve that closes the airway during maximal inspiration pressure and expiration. Maximal inspiration pressure is the highest pressure created to open closed alveoli at the residual volume level. In our study, respiratory muscle strength will be performed using a portable, electronic mouth pressure measuring with device. For the test, the applied person is given maximum expiration and at the end of this, the airway is closed with a valve and the person is asked to make maximum inspiration and continue it for 1-3 seconds. In the maximal expiration pressure measurement, after maximal inspiration, the person is asked to make a maximal expiration for 1-3 seconds against the closed airway. The best of the three measurements is selected. There should be no more than 10% or more than 10 cmH2O difference between the two best measured Change from baseline Maximal inspiratory and expiratory pressure at 5th day]
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