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

University of Sao Paulo

Status: Unknown

Conditions: Pectus Carinatum, Chondromanubrial

Treatments: Device: Thoracic compressor

Study type: Interventional

Funder types: Other

Identifiers

NCT04171063

USaoPauloGH

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 6 to 16 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Bracing arm

Other group

Description:

Patients that will be using the thoracic compressor

Treatment:

Device: Thoracic compressor