NCT07844382

Brief Summary

Pectus excavatum (PE) and pectus carinatum (PC) are chest wall deformities that may influence respiratory function, physical capacity, posture, and quality of life. This observational, cross-sectional study aims to provide a comprehensive and multidimensional evaluation of children with PE and PC and compare their findings with healthy controls. By examining multiple aspects of respiratory and physical function, postural characteristics, and quality of life, the study seeks to provide a broader understanding of the overall impact of these deformities.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
186

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2026

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 28, 2026

Completed
Last Updated

September 28, 2026

Status Verified

September 1, 2026

Enrollment Period

9 months

First QC Date

September 8, 2026

Last Update Submit

September 21, 2026

Conditions

Keywords

Respiratory FunctionFunctional CapacityPostureQuality of Life

Outcome Measures

Primary Outcomes (4)

  • Forced Vital Capacity (FVC)

    Forced vital capacity (FVC) was assessed using spirometry and expressed as a percentage of the predicted value.

    Baseline

  • Forced Expiratory Volume in One Second (FEV1)

    Forced expiratory volume in one second (FEV1) was assessed using spirometry and expressed as a percentage of the predicted value.

    Baseline

  • FEV1/FVC Ratio

    The FEV1/FVC ratio was assessed using spirometry and expressed as a percentage of the predicted value.

    Baseline

  • Maximal Voluntary Ventilation (MVV)

    Maximal voluntary ventilation (MVV) was assessed using spirometry and expressed as a percentage of the predicted value.

    Baseline

Secondary Outcomes (12)

  • Respiratory Muscle Strength

    Baseline

  • Physical Activity Level

    Baseline

  • Aerobic Capacity

    Baseline

  • Body Composition

    Baseline

  • Handgrip Strength

    Baseline

  • +7 more secondary outcomes

Study Arms (3)

Pectus Excavatum Group

Participants diagnosed with pectus excavatum

Pectus Carinatum

Participants diagnosed with pectus carinatum

Healthy Control Group

Age-matched healthy participants without pectus deformity

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population consisted of individuals aged 10-18 years diagnosed with pectus excavatum or pectus carinatum at a specialized thoracic surgery clinic and age-matched healthy controls

You may qualify if:

  • Individuals aged 10-18 years with pectus excavatum
  • Individuals aged 10-18 years with pectus carinatum
  • Healthy volunteers aged 10-18 years

You may not qualify if:

  • Previous conservative or surgical treatment for pectus excavatum
  • Major surgery within the previous 6 months
  • Congenital or acquired cardiac disease
  • Congenital or acquired pulmonary disease
  • Neuromuscular or orthopedic disease
  • Connective tissue disorders (Marfan syndrome, Turner syndrome, neurofibromatosis, or tuberous sclerosis)
  • Diagnosed psychological or cognitive problems
  • Obesity or severe underweight (BMI below the 5th percentile or above the 95th percentile)
  • Hearing or visual impairment not corrected with hearing aids or glasses
  • Acute infection, including an acute respiratory tract infection within the previous 2 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pektus Klinik

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Funnel ChestPectus CarinatumRespiratory Aspiration

Condition Hierarchy (Ancestors)

Bone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCartilage DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesRespiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Emine H Tüzün, PhD

    Eastern Mediterranean University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2026

First Posted

September 28, 2026

Study Start

November 20, 2025

Primary Completion

August 22, 2026

Study Completion

August 22, 2026

Last Updated

September 28, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

IPD sharing is not planned due to participant confidentiality

Locations