Clinical trial NCT04171063: Chest Compressor for Conservative Treatment of Pectus Carinatum: a Multicenter Study
Official title: Safety and Efficacy of a Modular and Adjustable Chest Compressor Model for Conservative Treatment of Pectus Carinatum: a Multicenter Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pectus Carinatum, Chondromanubrial
Keywords: Braces
Conservative treatment
Thoracic wall
Pectus carinatum
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2019-11-20
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients will be allocated to use the thoracic compressor for 16 months
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Treatment efficiency in repairing the pectus carinatum
timeFrame: 16 months
measure: Treatment safety
timeFrame: 16 months
Secondary outcomes:
measure: Treatment adherence
timeFrame: 16 months
measure: Device durability
timeFrame: 16 months
Other outcomes:
Locations:
city: Botucatu
country: Brazil
facility: Hospital de Clinicas da Faculdade de Botucatu
state: SP
city: Campinas
country: Brazil
facility: Hospital das Clinicas da Unicamp
state: SP
city: Sao Paulo
country: Brazil
facility: Instituto do Coracao (InCor) HCFMUSP
state: SP
city: Ribeirão Preto
country: Brazil
facility: Hospital das Clinicas da USP Ribeirao
Study officials:
affiliation: Instituto do Coracao (InCor) HCFMUSP
name: Miguel Tedde, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kelly RE Jr, Lawson ML, Paidas CN, Hruban RH. Pectus excavatum in a 112-year autopsy series: anatomic findings and the effect on survival. J Pediatr Surg. 2005 Aug;40(8):1275-8. doi: 10.1016/j.jpedsurg.2005.05.010.
citation: Shamberger RC. Congenital chest wall deformities. Curr Probl Surg. 1996 Jun;33(6):469-542. doi: 10.1016/s0011-3840(96)80005-0. No abstract available.
citation: Kelly RE Jr, Shamberger RC, Mellins RB, Mitchell KK, Lawson ML, Oldham K, Azizkhan RG, Hebra AV, Nuss D, Goretsky MJ, Sharp RJ, Holcomb GW 3rd, Shim WK, Megison SM, Moss RL, Fecteau AH, Colombani PM, Bagley TC, Moskowitz AB. Prospective multicenter study of surgical correction of pectus excavatum: design, perioperative complications, pain, and baseline pulmonary function facilitated by internet-based data collection. J Am Coll Surg. 2007 Aug;205(2):205-16. doi: 10.1016/j.jamcollsurg.2007.03.027. Epub 2007 Jun 21.
citation: Desmarais TJ, Keller MS. Pectus carinatum. Curr Opin Pediatr. 2013 Jun;25(3):375-81. doi: 10.1097/MOP.0b013e3283604088.