COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Lung Ultrasound for the Postoperative Diagnosis of Pneumothorax in Children (ECO_NUSS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03073616
Recruitment Status : Completed
First Posted : March 8, 2017
Last Update Posted : August 7, 2019
Information provided by (Responsible Party):
Nicola Disma, MD, Istituto Giannina Gaslini

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.

Condition or disease Intervention/treatment
Pectus Excavatum Device: Lung ultrasound

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 66 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Lung ultrasound
Every patient will receive a chest RX and lung US
Device: Lung ultrasound
Lung ultrasound and chest RX

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
66 consecutive pediatric patients undergoing Nuss procedure for Pectus Excavatum correction at Giannina Gaslini Institute, Genova, Italy

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03073616

Layout table for location information
Istituto Giannina Gaslini
Genova, Italy
Sponsors and Collaborators
Nicola Disma, MD
Layout table for additonal information
Responsible Party: Nicola Disma, MD, Principal Investigator, Istituto Giannina Gaslini Identifier: NCT03073616    
Other Study ID Numbers: Lung-US in children
First Posted: March 8, 2017    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Funnel Chest
Pleural Diseases
Respiratory Tract Diseases
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Musculoskeletal Abnormalities
Congenital Abnormalities