ECO_NUSS: Lung Ultrasound for the Postoperative Diagnosis of Pneumothorax in Children

Sponsor
Nicola Disma, MD (Other)
Overall Status
Completed
CT.gov ID
NCT03073616
Collaborator
(none)
66
1
21
3.1

Study Details

Study Description

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 Phase
  • 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.

Study Design

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 :
Apr 1, 2017
Actual Primary Completion Date :
Dec 31, 2018
Actual Study Completion Date :
Dec 31, 2018

Arms and Interventions

Arm Intervention/Treatment
Lung ultrasound

Every patient will receive a chest RX and lung US

Device: Lung ultrasound
Lung ultrasound and chest RX

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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)

  2. Postoperative complications [5 days after surgery]

    Incidence of Postoperative Pulmonary Complication

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istituto Giannina Gaslini Genova Italy

Sponsors and Collaborators

  • Nicola Disma, MD

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nicola Disma, MD, Principal Investigator, Istituto Giannina Gaslini
ClinicalTrials.gov Identifier:
NCT03073616
Other Study ID Numbers:
  • Lung-US in children
First Posted:
Mar 8, 2017
Last Update Posted:
Aug 7, 2019
Last Verified:
Aug 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 7, 2019