Lung Ultrasound for the Postoperative Diagnosis of Pneumothorax in Children

Completed

• Conditions: Pectus Excavatum
• Interventions: Device: Lung ultrasound

• Registration Number: NCT03073616
• Lead Sponsor: Nicola Disma, MD

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-02-20
• Study First Submitted QC: 2017-03-02
• Study First Posted: 2017-03-08
• Study Start: 2017-04-01
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-06
• Last Update Posted: 2019-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lung ultrasound	Lung ultrasound	Every patient will receive a chest RX and lung US

Primary Outcome Measures

Name	Time	Method
Detection of PNX	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 Outcome Measures

Name	Time	Method
Lung ultrasound and operator, composite measurement	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	5 days after surgery	Incidence of Postoperative Pulmonary Complication

Trial Locations

Locations (1)

Istituto Giannina Gaslini; 🇮🇹 Genova, Italy