Lung Ultrasound for the Postoperative Diagnosis of Pneumo... | NCT03073616

Studies
Lung Ultrasound for the Postoperative Diagnosis of Pneumothorax in Children

NCT03073616

Sponsor

Nicola Disma, MD

Status

Completed

Last Update Posted

Aug 7, 2019Actual

Enrollment

66Actual

Phase

Not provided

Conditions

Pectus Excavatum

Interventions

Lung ultrasound

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2017Actual

Primary Completion Date

Dec 31, 2018Actual

Completion Date

Dec 31, 2018Actual

First Submitted Date

Feb 20, 2017

First Submission Date that Met QC Criteria

Mar 2, 2017

First Posted Date

Mar 8, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 6, 2019

Last Update Posted Date

Aug 7, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nicola Disma, MD, Principal Investigator, Istituto Giannina GasliniSponsor-Investigator

Lead Sponsor

Nicola Disma, MDOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

66Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lung ultrasound		Every patient will receive a chest RX and lung US	Device: Lung ultrasound

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lung ultrasound	Device	Lung ultrasound and chest RX	Lung ultrasound

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Detection of PNX	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).	60 minutes after the end of surgery

Secondary Outcomes

Measure	Description	Time Frame
Lung ultrasound and operator, composite measurement	The diagnosis of "PNX" and "no PNX" has to be in agreement between operators (anesthesiologist and student)	Before surgery, 60 minutes after surgery and 24 hours after surgery
Postoperative complications

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

66 consecutive pediatric patients undergoing Nuss procedure for Pectus Excavatum correction at Giannina Gaslini Institute, Genova, Italy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istituto Giannina Gaslini		Genova			Italy

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005660	Funnel Chest

Ancestor Terms

ID	Term
D001848	Bone Diseases, Developmental
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D009139	Musculoskeletal Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided