Lung Ultrasound for the Postoperative Diagnosis of Pneumothorax in Children (ECO_NUSS)
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|ClinicalTrials.gov Identifier: NCT03073616|
Recruitment Status : Completed
First Posted : March 8, 2017
Last Update Posted : August 7, 2019
|Condition or disease||Intervention/treatment|
|Pectus Excavatum||Device: Lung ultrasound|
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.
|Study Type :||Observational|
|Actual Enrollment :||66 participants|
|Official Title:||Is Lung Ultrasound the Technique of Choice for the Diagnosis of Pneumothorax Following the Nuss Procedure for Pectus Excavatum?|
|Actual Study Start Date :||April 1, 2017|
|Actual Primary Completion Date :||December 31, 2018|
|Actual Study Completion Date :||December 31, 2018|
Every patient will receive a chest RX and lung US
Device: Lung ultrasound
Lung ultrasound and chest RX
- 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).
- 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)
- Postoperative complications [ Time Frame: 5 days after surgery ]Incidence of Postoperative Pulmonary Complication
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03073616
|Istituto Giannina Gaslini|