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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.
 
ClinicalTrials.gov Identifier: NCT03073616
Recruitment Status : Completed
First Posted : March 8, 2017
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Nicola Disma, MD, Istituto Giannina Gaslini

Tracking Information
First Submitted Date February 20, 2017
First Posted Date March 8, 2017
Last Update Posted Date August 7, 2019
Actual Study Start Date April 1, 2017
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 2, 2017)
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).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 2, 2017)
  • 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)
  • Postoperative complications [ Time Frame: 5 days after surgery ]
    Incidence of Postoperative Pulmonary Complication
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Lung Ultrasound for the Postoperative Diagnosis of Pneumothorax in Children
Official Title Is Lung Ultrasound the Technique of Choice for the Diagnosis of Pneumothorax Following the Nuss Procedure for Pectus Excavatum?
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 Type Observational
Study Design Observational Model: Case-Crossover
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 66 consecutive pediatric patients undergoing Nuss procedure for Pectus Excavatum correction at Giannina Gaslini Institute, Genova, Italy
Condition Pectus Excavatum
Intervention Device: Lung ultrasound
Lung ultrasound and chest RX
Study Groups/Cohorts Lung ultrasound
Every patient will receive a chest RX and lung US
Intervention: Device: Lung ultrasound
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 2, 2017)
66
Original Estimated Enrollment Same as current
Actual Study Completion Date December 31, 2018
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT03073616
Other Study ID Numbers Lung-US in children
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Nicola Disma, MD, Istituto Giannina Gaslini
Study Sponsor Nicola Disma, MD
Collaborators Not Provided
Investigators Not Provided
PRS Account Istituto Giannina Gaslini
Verification Date August 2019