Ultrasonographic Measurement of Diaphragmatic Thickness in Adolescents With Pectus Deformity

Pectus Excavatum Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06392984
• Other study ID #: 98
• Status: Recruiting
• Start date: February 21, 2024
• Est. completion date: April 30, 2024

Study information

• Verified date: March 2024
• Source: Gaziosmanpasa Research and Education Hospital
• Contact: Zeynel Karakullukcuoglu, MD
• Phone: +90 541 216 61 16
• Email: zeynel[@]uludag.edu.tr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 30, 2024
• Est. primary completion date: April 25, 2024
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

Inclusion Criteria:

• Increased thoracal kyphosis (thoracic hyperkyphosis)
• Being between the ages of 10-18
• 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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Funnel Chest
• Pectus Carinatum
• Pectus Deformity
• Pectus Excavatum

Intervention

Diagnostic Test:
• Pectus deformity study form
Pectus deformity study form consisting of clinical and radiological measurements of participants aged 10-18 years who applied to the outpatient clinic with chest deformity will be filled in detail.
• Pulmonary 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.
• 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.

Locations

Country	Name	City	State
Turkey	Zeynel Karakullukcuoglu,	Istanbul	Gaziosmanpasa

Sponsors (1)

Lead Sponsor	Collaborator
Gaziosmanpasa Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

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; — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pectus deformity study form	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.	Within 1 month of applying to the outpatient clinic
Primary	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
Primary	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