Chest Compressor for Conservative Treatment of Pectus Carinatum: a Multicenter Study

Not Applicable

• Conditions: Pectus Carinatum, Chondromanubrial
• Interventions: Device: Thoracic compressor

• Registration Number: NCT04171063
• Lead Sponsor: University of Sao Paulo

Brief Summary

Pectus carinatum (PC) is a congenital deformity of the chest wall whose prevalence is 0.6% of the population and although it does not cause cardio respiratory physiological damage, it has profound psychological effects on young people. Its treatment today is still primarily surgical in our country, despite the fact that conservative treatment by chest compression may be effective in the chondrogladiolar variant, which represents 90% of cases of PC. The aim of the present study is to conservatively treat a series of 60 patients using a new modular and adjustable chest compressor model to assess the effectiveness of this chest compressor in the noninvasive treatment of PC; and also assess the safety of such treatment by the rate of adverse events occurring during treatment. Secondary objectives will be to evaluate the adherence that PC patients have to this type of treatment by quantifying the number of hours of use per day, besides evaluating the chest compressor and its components for durability and resistance as a device for continuous use.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-01
• Study First Submitted: 2019-11-07
• Study First Submitted QC: 2019-11-18
• Study First Posted: 2019-11-20
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-09
• Last Update Posted: 2021-10-12
• Primary Completion: 2022-06-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Pectus carinatum condrogladiolar Variant
• No other comorbidities that could interfere with the use of compressor

Exclusion Criteria

• Marfan Syndrome
• Active cardiovascular disease
• Significant scoliosis or thoracic deformity
• Important obesity
• Pectus carinatum chondromanubrial variant
• Poor commitment to protocol by both research participant and parents

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bracing arm	Thoracic compressor	Patients that will be using the thoracic compressor

Primary Outcome Measures

Name	Time	Method
Treatment safety	16 months	The adverse events that can possibly occur during treatment will be recorded in the patients using the chest compressor for pectus carinatum repair
Treatment efficiency in repairing the pectus carinatum	16 months	The anthroprometric measures in centimeters of the thoracic cage will be taken before and after the treatment to evaluate the effectiveness of the chest compressor in repairing the pectus carinatum

Secondary Outcome Measures

Name	Time	Method
Treatment adherence	16 months	The number of hours of daily use of the chest compressor will be recorded as a measurement of the level of adherence to the chest compressor treatment
Device durability	16 months	The mechanic problems presented by the chest compressor as fractures, screw loosening or fastener break will be recorded as a durability and strength measure of the chest compressor and its components.

Trial Locations

Locations (4)

Hospital das Clinicas da USP Ribeirao; 🇧🇷 Ribeirão Preto, Brazil

Instituto do Coracao (InCor) HCFMUSP; 🇧🇷 Sao Paulo, SP, Brazil

Hospital de Clinicas da Faculdade de Botucatu; 🇧🇷 Botucatu, SP, Brazil

Hospital das Clinicas da Unicamp; 🇧🇷 Campinas, SP, Brazil