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Clinical Trials/NCT03073616
NCT03073616
Completed
Not Applicable

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

Nicola Disma, MD1 site in 1 country66 target enrollmentApril 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pectus Excavatum
Sponsor
Nicola Disma, MD
Enrollment
66
Locations
1
Primary Endpoint
Detection of PNX
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2017
End Date
December 31, 2018
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Nicola Disma, MD
Responsible Party
Sponsor Investigator
Principal Investigator

Nicola Disma, MD

Principal Investigator

Istituto Giannina Gaslini

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

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

Study Sites (1)

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