Safety and Efficacy of a Modular and Adjustable Chest Compressor Model for Conservative Treatment of Pectus Carinatum: a Multicenter Study
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Treatment safety
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 16 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pectus carinatum condrogladiolar Variant
- •No other comorbidities that could interfere with the use of compressor
排除标准
- •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
结局指标
主要结局
Treatment safety
时间窗: 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
时间窗: 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
次要结局
- Device durability(16 months)
- Treatment adherence(16 months)
研究者
Miguel L. Tedde
Staff Physician, General Thoracic Surgery Department
University of Sao Paulo
