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临床试验/NCT03073616
NCT03073616已完成不适用

Is Lung Ultrasound the Technique of Choice for the Diagnosis of Pneumothorax Following the Nuss Procedure for Pectus Excavatum?

Nicola Disma, MD1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2017年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
66
试验地点
1
主要终点
Detection of PNX

研究概览

简要总结

This study will be conducted to determine the advantages and limitations of sonography compared with chest radiography, in the detection of post procedure iatrogenic pneumothorax in patients underwent to Pectus Excavatum (PE) with Nuss repair.

详细描述

The Nuss procedure is a minimally invasive technique for the repair of Pectus Excavatum (MIRPE).

Residual pneumothorax (PNX) is reported in more than 50% after Nuss procedure. It is a consequence of the introduction of the scope and bar in the pleural space and is considered a minor complication due to the minimal clinical consequences. It is routine practice to confirm the diagnosis of PNX with a conventional chest X-Ray either in the operating room at the end of thoracic surgery or in the recovery room unit immediately after surgery.However, anterior pneumothorax can occur and chest-X ray could not be able to detected the PNX. Nowadays lung ultrasound (LUS) allows a bedside non-invasive evaluation of the patient(with a sensitivity and specificity of 92 and 99% respectively) without exposure to ionized radiation, can be performed more quickly than chest radiography and therefore can be repeated several times without additional risks. The use of LUS in pediatric age groups is more recent, but is becoming widely utilized both in neonatal and pediatric respiratory diseases.

Bedside sonography for diagnosis of PNX has been well described in emergency and trauma medicine literature and it is resulted to be more sensitive and specific than portable anteroposterior chest radiography. Although there are few studies describing the use of ultrasound for the detection of surgical pneumothorax, none of them studied its use after Nuss Procedure.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients following Nuss procedure for PE repair at Giannina Gaslini Institute

排除标准

  • absence of informed consent from parents
  • poor quality of the pre-operatory acoustic window

结局指标

主要结局

Detection of PNX

时间窗: 60 minutes after the end of surgery

Detection of residual PNX immediately after surgery for NUSS repair, either using lung ultrasound (LUS): sliding (Y/N), line B (Y/N), lung pulse (Y/N), lung point (Y/N) and Rx PNX=Y/N).

次要结局

  • Lung ultrasound and operator, composite measurement(Before surgery, 60 minutes after surgery and 24 hours after surgery)
  • Postoperative complications(5 days after surgery)

研究者

发起方
Nicola Disma, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nicola Disma, MD

Principal Investigator

Istituto Giannina Gaslini

研究点 (1)

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