Lung Ultrasound for the Postoperative Diagnosis of Pneumothorax in Children

Pectus Excavatum Clinical Trial

— ECO_NUSS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03073616
• Other study ID #: Lung-US in children
• Status: Completed
• Start date: April 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: August 2019
• Source: Istituto Giannina Gaslini
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Funnel Chest
• Pectus Excavatum
• Pneumothorax

Intervention

Device:
• Lung ultrasound
Lung ultrasound and chest RX

Locations

Country	Name	City	State
Italy	Istituto Giannina Gaslini	Genova

Sponsors (1)

Lead Sponsor	Collaborator
Nicola Disma, MD

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of PNX	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).	60 minutes after the end of surgery
Secondary	Lung ultrasound and operator, composite measurement	The diagnosis of "PNX" and "no PNX" has to be in agreement between operators (anesthesiologist and student)	Before surgery, 60 minutes after surgery and 24 hours after surgery
Secondary	Postoperative complications	Incidence of Postoperative Pulmonary Complication	5 days after surgery