Clinical trial NCT06392984: Ultrasonographic Measurement of Diaphragmatic Thickness in Adolescents With Pectus Deformity
Official title: Ultrasonographic Measurement of Diaphragmatic Thickness in Adolescents With Pectus Deformity: Is it an Early Predictor of Respiratory Dysfunction?
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pectus Deformity
Pectus Excavatum
Pectus Carinatum
Pectus Abnormalities
Keywords: Pectus Deformity
Pectus Abnormalities
Diaphragma Thickness
Ultrasonographic Measurement
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2024-05-01
Enrollment: 40
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pectus deformity study form
timeFrame: Within 1 month of applying to the outpatient clinic
measure: Pulmonary function test
timeFrame: Within 1 month of applying to the outpatient clinic
measure: Ultrasonographic Diaphragm Thickness Measurement
timeFrame: Within 1 month of applying to the outpatient clinic
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Zeynel Karakullukcuoglu,
state: Gaziosmanpasa
Study officials:
affiliation: Gaziosmanpasa Training and Research Hospital Physical Rehabilitation Department
name: Meryem Guneser Gulec, MD
role: STUDY_CHAIR
affiliation: Medical Park Bahcelievler Hospital Physical Medicine and Rehabilitation Department
name: Cansu Ozkan, MD
role: STUDY_CHAIR
References:
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;8(1):e001020. doi: 10.1136/bmjresp-2021-001020.
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.
citation: 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.