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临床试验/NCT06572709
NCT06572709招募中不适用

Ultrasonographic Evaluation of Parasternal Intercostal Muscles and Their Correlation With Respiratory Function Test in Stroke Patients

Fatih Sultan Mehmet Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年8月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Parasternal intercostal muscle thickness and thickening ratio

研究概览

简要总结

Ultrasonographic evaluation of parasternal intercostal muscles and to determine whether there is a correlation with PFT parameters in stroke patients

详细描述

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], FEV1/FVC, 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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
30 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ischemic or Hemorrhagic stroke patients, Stroke duration >6 months, Mini-mental test score >24

排除标准

  • Individuals with acute or chronic lung disease, Patients with a history of thoracic or abdominal surgery, Patients with other neuromuscular diseases, Aphasia type with impaired understanding, Facial paralysis

结局指标

主要结局

Parasternal intercostal muscle thickness and thickening ratio

时间窗: 15 minute

Parasternal intercostal muscle ultrasonographic millimetric measurement

次要结局

  • Correlation between parasternal intercostal muscle thicknesses and spirometry parameters(15 minute)

研究者

发起方
Fatih Sultan Mehmet Training and Research Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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