Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06572709
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
Ultrasonographic Evaluation of Parasternal Intercostal Muscles in Stroke Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Ultrasonographic Evaluation of Parasternal Intercostal Muscles and Their Correlation With Respiratory Function Test in Stroke Patients
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UEPIMSP
Brief Summary:
Ultrasonographic evaluation of parasternal intercostal muscles and to determine whether there is a correlation with PFT parameters in stroke patients
Detailed Description:
The clinical study planned as a cross-sectional prospective will be conducted on 30 stroke patients followed in the same stroke clinic and a total of 30 healthy volunteers of similar age and gender to the stroke patients Patients with ischemic or hemorrhagic stroke with stroke duration 6 months and mini-mental test score 24 will be included in the study Stroke patients with acute or chronic lung disease a history of thoracic surgery another neuromuscular disease aphasia type in which comprehension is impaired and facial paralysis will not be included in the study Written informed consent will be obtained from those who meet the study criteria and agree to participate in the study
Demographic data of patients and healthy volunteers gender age height weight body mass index dominant extremity stroke etiology duration side respiratory function test PFT parameters measurement results bilateral parasternal intercostal muscle thickness in stroke patients and the dominant side parasternal intercostal muscle thicknesses in healthy volunteers will be measured with Ultrasound US thickening rates will be calculated and recorded
All participants will be evaluated in B-mode using the MyLab60 brand US device with 7-12 MHz linear probe Measurements will be taken at the end of tidal expiration and maximal inspiration while the participants are in the supine position To evaluate intercostal muscle thickness measurements will be made between the 2nd and 3rd ribs 3 cm lateral to the sternum in accordance with the literature The probe will be placed vertically at this point in the sagittal plane a vertical caliper will be drawn between the hyperechoic fascia lines on the pleura and this distance will be recorded in millimeters All measurements will be repeated 3 times the average value will be recorded and thickening rates will be calculated The formula end-inspiratory thickness - end-expiratory thickness end-expiratory thickness will be used to calculate the thickening ratio US evaluation of each participant will be performed by an experienced physician with more than 5 years of experience in this field
Respiratory functions of the individuals included in the study will be measured with a CHEST HI-105 10510759 model spirometer according to the American Thoracic Society and European Respiratory Society criteria Forced vital capacity FVC forced expiratory volume in 1 second FEV1 FEV1FVC maximal expiratory flow rate PEF values and their percentage predictive values will be recorded MicroRPM Respiratory Meter device MicroDirect USA will be used for respiratory muscle strength measurements maximum inspiratory pressure MIP maximum expiratory pressure MEP PFT of all participants will be performed by a different researcher who is blind to the US measurement results
Demographic data of patients and healthy volunteers gender age height weight body mass index dominant extremity stroke etiology duration side respiratory function test PFT parameters measurement results bilateral parasternal intercostal muscle thickness in stroke patients and the dominant side parasternal intercostal muscle thicknesses in healthy volunteers will be measured with Ultrasound US thickening rates will be calculated and recorded
All participants will be evaluated in B-mode using the MyLab60 brand US device with 7-12 MHz linear probe Measurements will be taken at the end of tidal expiration and maximal inspiration while the participants are in the supine position To evaluate intercostal muscle thickness measurements will be made between the 2nd and 3rd ribs 3 cm lateral to the sternum in accordance with the literature The probe will be placed vertically at this point in the sagittal plane a vertical caliper will be drawn between the hyperechoic fascia lines on the pleura and this distance will be recorded in millimeters All measurements will be repeated 3 times the average value will be recorded and thickening rates will be calculated The formula end-inspiratory thickness - end-expiratory thickness end-expiratory thickness will be used to calculate the thickening ratio US evaluation of each participant will be performed by an experienced physician with more than 5 years of experience in this field
Respiratory functions of the individuals included in the study will be measured with a CHEST HI-105 10510759 model spirometer according to the American Thoracic Society and European Respiratory Society criteria Forced vital capacity FVC forced expiratory volume in 1 second FEV1 FEV1FVC maximal expiratory flow rate PEF values and their percentage predictive values will be recorded MicroRPM Respiratory Meter device MicroDirect USA will be used for respiratory muscle strength measurements maximum inspiratory pressure MIP maximum expiratory pressure MEP PFT of all participants will be performed by a different researcher who is blind to the US measurement results
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None