Ultrasonographic Measurement of Diaphragmatic Thickness in Adolescents With Pectus Deformity

NCT06392984 | Completed

• 1 other identifier: 98
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Pectus Deformity; Pectus Excavatum; Pectus Carinatum; Pectus Abnormalities

Keywords

Pectus Deformity; Pectus Abnormalities; Diaphragma Thickness; Ultrasonographic Measurement

Outcome Measures

Primary Outcomes (3)

• Pectus deformity study form

  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.

  Within 1 month of applying to the outpatient clinic

• Pulmonary function test

  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.

  Within 1 month of applying to the outpatient clinic

• Ultrasonographic Diaphragm Thickness Measurement

  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.

  Within 1 month of applying to the outpatient clinic

Study Arms (2)

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.

Diagnostic Test: Pectus deformity study form; Diagnostic Test: Pulmonary function test; Diagnostic Test: Ultrasonographic Diaphragm Thickness Measurement

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.

Diagnostic Test: Pectus deformity study form; Diagnostic Test: Pulmonary function test; Diagnostic Test: Ultrasonographic Diaphragm Thickness Measurement

Interventions

Pectus deformity study form DIAGNOSTIC_TEST

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

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

Pulmonary function test DIAGNOSTIC_TEST

Pulmonary function tests (PFTs) are noninvasive tests that show how well the lungs are working. The tests measure lung volume, capacity, rates of flow, and gas exchange. This information can help your healthcare provider diagnose and decide the treatment of certain lung disorders. Investigators 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.

Also known as: • Spirometry Function Test

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

Ultrasonographic Diaphragm Thickness Measurement DIAGNOSTIC_TEST

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.

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

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

It will consist of participants with pectus deformity who apply to the Physical Medicine and Rehabilitation Clinic of the University of Health Sciences Gaziosmanpaşa Training and Research Hospital within the study date ranges, meet the inclusion and exclusion criteria and voluntarily agree to participate in the research. Healthy individuals identical in age and gender will be included in the study as a control group. Demographic information of all individuals involved in the recruitment will be collected.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gaziosmanpasa Research and Education Hospital: lead

Study Sites (1)

Zeynel Karakullukcuoglu,

Istanbul, Gaziosmanpasa, 34255, Turkey (Türkiye)

Location

Related Publications (3)

• Ramadan S, Wilde J, Tabard-Fougere A, Toso S, Beghetti M, Vallee JP, Corbelli R, Barazzone-Argiroffo C, Lascombes P, Ruchonnet-Metrailler I. Cardiopulmonary function in adolescent patients with pectus excavatum or carinatum. BMJ Open Respir Res. 2021 Jul;8(1):e001020. doi: 10.1136/bmjresp-2021-001020.

  PMID: 34326157 RESULT

• Tomaszewski R, Wiktor L, Machala L. Evaluation of thoracic vertebrae rotation in patients with pectus excavatum. Acta Orthop Traumatol Turc. 2017 Jul;51(4):284-289. doi: 10.1016/j.aott.2017.03.005. Epub 2017 Jun 16.

  PMID: 28624480 RESULT

• Azimi G, Bozorgmehr R, Sattari P, Azimi A, Azimi H, Marzban-Rad S. Physiologic function of mediastinum space. Ann Med Surg (Lond). 2022 Sep 15;82:104670. doi: 10.1016/j.amsu.2022.104670. eCollection 2022 Oct.

  PMID: 36268434 RESULT

MeSH Terms

Conditions

Funnel Chest; Pectus Carinatum

Interventions

Respiratory Function Tests

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cartilage Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Meryem Guneser Gulec, MD

  Gaziosmanpasa Training and Research Hospital Physical Rehabilitation Department

  STUDY CHAIR

• Cansu Ozkan, MD

  Medical Park Bahcelievler Hospital Physical Medicine and Rehabilitation Department

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2024
• First Posted: May 1, 2024
• Study Start: October 1, 2023
• Primary Completion: May 27, 2024
• Study Completion: May 27, 2024
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

TU (1)