- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06392984
Ultrasonographic Measurement of Diaphragmatic Thickness in Adolescents With Pectus Deformity
Ultrasonographic Measurement of Diaphragmatic Thickness in Adolescents With Pectus Deformity: Is it an Early Predictor of Respiratory Dysfunction?
Study Overview
Status
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Gaziosmanpasa
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Istanbul, Gaziosmanpasa, Turkey (Türkiye), 34255
- Zeynel Karakullukcuoglu,
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Increased thoracal kyphosis (thoracic hyperkyphosis)
- Being between the ages of 6-18
- Patients who can cooperate with spirometry.
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
Other Names:
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.
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
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.
|
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.
Other Names:
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pulmonary function test
Time Frame: 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.
|
Within 1 month of applying to the outpatient clinic
|
|
Ultrasonographic Diaphragm Thickness Measurement
Time Frame: 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.
|
Within 1 month of applying to the outpatient clinic
|
|
Pectus deformity study form
Time Frame: 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.
|
Within 1 month of applying to the outpatient clinic
|
Collaborators and Investigators
Investigators
- Study Chair: 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
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Bone Diseases
- Musculoskeletal Diseases
- Connective Tissue Diseases
- Musculoskeletal Abnormalities
- Congenital Abnormalities
- Bone Diseases, Developmental
- Cartilage Diseases
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Skin and Connective Tissue Diseases
- Funnel Chest
- Pectus Carinatum
- Diagnostic Techniques and Procedures
- Diagnosis
- Diagnostic Techniques, Respiratory System
- Respiratory Function Tests
Other Study ID Numbers
- 98
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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