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临床试验/NCT06392984
NCT06392984已完成不适用

Ultrasonographic Measurement of Diaphragmatic Thickness in Adolescents With Pectus Deformity: Is it an Early Predictor of Respiratory Dysfunction?

Gaziosmanpasa Research and Education Hospital1 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2023年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
61
试验地点
1
主要终点
Pectus deformity study form

研究概览

简要总结

Pectus deformities are among the most common anterior chest wall pathologies. Pectus excavatum is the most common chest deformity with an incidence of 0.1-0.3%. In severe deformities, a decrease in lung volume is observed. This can cause decreased pulmonary function and affect the function of the right ventricle. The diaphragm is the main respiratory muscle, and diaphragm contraction is associated with respiratory functions. So, investigators aimed to measure diaphragmatic thickness in adolescents with pectus deformity and to show whether diaphragmatic thickness is an early predictor of respiratory disorder in participants who do not show any clinical symptoms or whose respiratory functions are normal.

详细描述

Pectus deformities are among the most common anterior chest wall pathologies. Pectus excavatum is the most common chest deformity with an incidence of 0.1-0.3%. It is more common in boys than girls at a ratio of 4:1. This deformity involves the lower part of the body of the sternum; The chest wall has shifted posteriorly.

Pectus excavatum is a cosmetic defect that in most cases does not have physiological consequences. In severe deformities, a decrease in lung volume is observed. This can cause decreased pulmonary function and affect the function of the right ventricle. Funnel chest defects can cause chest pain, shortness of breath, decreased cardiac output, and decreased exercise capacity, depending on the depth of the deformity.

The alignment of the skeletal system in the chest and its harmony with the compliance of the chest wall are related to respiratory function; changes in the rib cage lead to a decrease in lung capacity. The diaphragm is the main respiratory muscle, and diaphragm contraction is associated with respiratory functions. In recent years, ultrasonography (USG) has gained increasing utility for visualizing the diaphragm and assessing its function, with several advantages.

Based on this, investigators aimed to measure diaphragmatic thickness in adolescents with pectus deformity and to show whether diaphragmatic thickness is an early predictor of respiratory disorder in participants who do not show any clinical symptoms or whose respiratory functions are normal.

研究设计

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

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Increased thoracal kyphosis (thoracic hyperkyphosis)
  • Being between the ages of 6-18
  • Patients who can cooperate with spirometry.

排除标准

  • Congenital spinal, costal and diaphragmatic anomalies
  • Neuromuscular disease
  • Respiratory system diseases that affect lung functions
  • Patients who cannot cooperate with spirometry.
  • Having surgery to the chest wall or spine

研究组 & 干预措施

Participants aged 6-18 years who were diagnosed with pectus deformity

Pectus deformity study form consisting of clinical and radiological measurements of participants aged 6-18 years who were diagnosed with pectus deformity and applied to the scoliosis outpatient clinic will be filled in detail.

干预措施: Pectus deformity study form (Diagnostic Test)

Participants aged 6-18 years who were diagnosed with pectus deformity

Pectus deformity study form consisting of clinical and radiological measurements of participants aged 6-18 years who were diagnosed with pectus deformity and applied to the scoliosis outpatient clinic will be filled in detail.

干预措施: Pulmonary function test (Diagnostic Test)

Participants aged 6-18 years who were diagnosed with pectus deformity

Pectus deformity study form consisting of clinical and radiological measurements of participants aged 6-18 years who were diagnosed with pectus deformity and applied to the scoliosis outpatient clinic will be filled in detail.

干预措施: Ultrasonographic Diaphragm Thickness Measurement (Diagnostic Test)

Control group

Pectus deformity study form consisting of clinical and radiological measurements of participants aged 6-18 years who were diagnosed with normal and applied to the scoliosis outpatient clinic will be filled in detail.

干预措施: Pulmonary function test (Diagnostic Test)

Control group

Pectus deformity study form consisting of clinical and radiological measurements of participants aged 6-18 years who were diagnosed with normal and applied to the scoliosis outpatient clinic will be filled in detail.

干预措施: Ultrasonographic Diaphragm Thickness Measurement (Diagnostic Test)

Control group

Pectus deformity study form consisting of clinical and radiological measurements of participants aged 6-18 years who were diagnosed with normal and applied to the scoliosis outpatient clinic will be filled in detail.

干预措施: Pectus deformity study form (Diagnostic Test)

结局指标

主要结局

Pectus deformity study form

时间窗: Within 1 month of applying to the outpatient clinic

Pectus deformity study form consisting of clinical and radiological measurements of patients aged 6-18 years who applied to the outpatient clinic with chest deformity will be filled in detail.

Pulmonary function test

时间窗: Within 1 month of applying to the outpatient clinic

We will use handheld spirometry device for measurement. Three measurements will be made. In these three measurements; FEV1(Forced Expiratory Volume In One Second)(Liter-L), FEV1 (%predicted), FVC (Forced Vital Capacity) (Liter-L), FVC (%predicted), FEV1/FVC (%) and FEV1/FVC (%predicted) will be evaluated. The arithmetic average of the results of these three measurements will be taken.

Ultrasonographic Diaphragm Thickness Measurement

时间窗: Within 1 month of applying to the outpatient clinic

Diaphragm thickness (millimeter-mm) will be measured in the supine position with a 6-14 Mhz lineer, conventional ultrasound probe (Mindray DC-8, Shenzen Mindray Bio-Medical Electronics CO. LTD.,P.R. China) at the end of inspiration and expiration from the intercostal space on the anterior axillary line. The measurements will be evaluated by making three measurements from the right 8-9. intercostal space where the diaphragm is best visualized. End-expiratory (Forced residual capacity-FRC) (millimeter-mm), end-inspiratory (Total Lung Capacity-TLC) (millimeter-mm) and thickening rate (%) (thickness TLC / thickness FRC) will be evaluated three times and the arithmetic average of these three measurements will be taken.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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