Ultrasonographic Measurement of Diaphragmatic Thickness in Adolescents With Pectus Deformity

Recruiting

• Conditions: Pectus Excavatum; Pectus Abnormalities; Pectus Carinatum; Pectus Deformity
• Interventions: Diagnostic Test: Pectus deformity study form; Diagnostic Test: Pulmonary function test; Diagnostic Test: Ultrasonographic Diaphragm Thickness Measurement

• Registration Number: NCT06392984
• Lead Sponsor: Gaziosmanpasa Research and Education Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2024-02-21
• Status Verified: 2024-03
• Study First Submitted: 2024-03-30
• Primary Completion: 2024-04-25
• Study First Submitted QC: 2024-04-29
• Last Update Submitted: 2024-04-29
• Study Completion: 2024-04-30
• Study First Posted: 2024-05-01
• Last Update Posted: 2024-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Increased thoracal kyphosis (thoracic hyperkyphosis)
• Being between the ages of 10-18
• Patients who can cooperate with spirometry.

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Exclusion Criteria

• 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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants aged 10-18 years who were diagnosed with pectus deformity	Pectus deformity study form	Pectus deformity study form consisting of clinical and radiological measurements of participants aged 10-18 years who were diagnosed with pectus deformity and applied to the scoliosis outpatient clinic will be filled in detail.
Control group	Pulmonary function test	Pectus deformity study form consisting of clinical and radiological measurements of participants aged 10-18 years who were diagnosed with normal and applied to the scoliosis outpatient clinic will be filled in detail.
Control group	Pectus deformity study form	Pectus deformity study form consisting of clinical and radiological measurements of participants aged 10-18 years who were diagnosed with normal and applied to the scoliosis outpatient clinic will be filled in detail.
Participants aged 10-18 years who were diagnosed with pectus deformity	Pulmonary function test	Pectus deformity study form consisting of clinical and radiological measurements of participants aged 10-18 years who were diagnosed with pectus deformity and applied to the scoliosis outpatient clinic will be filled in detail.
Participants aged 10-18 years who were diagnosed with pectus deformity	Ultrasonographic Diaphragm Thickness Measurement	Pectus deformity study form consisting of clinical and radiological measurements of participants aged 10-18 years who were diagnosed with pectus deformity and applied to the scoliosis outpatient clinic will be filled in detail.
Control group	Ultrasonographic Diaphragm Thickness Measurement	Pectus deformity study form consisting of clinical and radiological measurements of participants aged 10-18 years who were diagnosed with normal and applied to the scoliosis outpatient clinic will be filled in detail.

Primary Outcome Measures

Name	Time	Method
Ultrasonographic Diaphragm Thickness Measurement	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.
Pulmonary function test	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.
Pectus deformity study form	Within 1 month of applying to the outpatient clinic	Pectus deformity study form consisting of clinical and radiological measurements of patients aged 10-18 years who applied to the outpatient clinic with chest deformity will be filled in detail.

Trial Locations

Locations (1)

Zeynel Karakullukcuoglu,; 🇹🇷 Istanbul, Gaziosmanpasa, Turkey