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CompletedNCT06392984Updated Jan 8, 2026

Ultrasonographic Measurement of Diaphragmatic Thickness in Adolescents With Pectus Deformity

An observational study in Pectus Deformity, Pectus Excavatum and Pectus Carinatum, sponsored by Gaziosmanpasa Research and Education Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-01-08.

Sponsored by Gaziosmanpasa Research and Education Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
61
Ages
6 Years to 18 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pectus Deformity
  • Pectus Excavatum
  • Pectus Carinatum
  • Pectus Abnormalities

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Keywords

  • Pectus Deformity
  • Pectus Abnormalities
  • Diaphragma Thickness
  • Ultrasonographic Measurement
03

In context

Funnel Chest

79 studies on the registry are indexed under Funnel Chest; 10 are open to participants now.

This study's enrollment of 61 is below the median of 68 across 32 observational studies indexed under Funnel Chest.

Browse Funnel Chest studies →

Lead sponsor

Gaziosmanpasa Research and Education Hospital is the lead sponsor of 126 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 18 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
61 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testPectus deformity study form

    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.

  • Diagnostic testPulmonary function 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

  • Diagnostic testUltrasonographic 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Within 1 month of applying to the outpatient clinic

  2. 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.

    Time frame: Within 1 month of applying to the outpatient clinic

  3. 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.

    Time frame: Within 1 month of applying to the outpatient clinic

07

Study locations

1 site
  • Zeynel Karakullukcuoglu,
    Istanbul, Gaziosmanpasa 34255, Turkey (Türkiye)
08

References and documents

Publications

  • 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. PubMed 34326157 ↗
  • 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. PubMed 28624480 ↗
  • 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. PubMed 36268434 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06392984
Responsible party
Sponsor
First posted
May 1, 2024
Start date
Oct 1, 2023
Primary completion
May 27, 2024
Completion
May 27, 2024
Last update
Jan 8, 2026

Study contacts

Meryem Guneser Gulec, MD
study chair · Gaziosmanpasa Training and Research Hospital Physical Rehabilitation Department
Cansu Ozkan, MD
study chair · Medical Park Bahcelievler Hospital Physical Medicine and Rehabilitation Department

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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