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Completed

NCT Number: NCT03073616

Lung Ultrasound for the Postoperative Diagnosis of Pneumothorax in Children

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Lung ultrasound

Device

Lung ultrasound and chest RX

Primary outcomes

  1. Detection of PNX

    Time frame: 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).

Secondary outcomes

  1. Lung ultrasound and operator, composite measurement

    Time frame: Before surgery, 60 minutes after surgery and 24 hours after surgery

    The diagnosis of "PNX" and "no PNX" has to be in agreement between operators (anesthesiologist and student)

  2. Postoperative complications

    Time frame: 5 days after surgery

    Incidence of Postoperative Pulmonary Complication

Sponsors and collaborators

Lead sponsor

Nicola Disma, MD

Other

Registry information

Official study title

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

Acronym: ECO_NUSS

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 8, 2017
Registry last updated
Aug 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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