NCT03073616

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 8, 2017

Completed
24 days until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

1.8 years

First QC Date

February 20, 2017

Last Update Submit

August 6, 2019

Conditions

Pectus Excavatum

Outcome Measures

Primary Outcomes (1)

  • 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 (2)

  • Lung ultrasound and operator, composite measurement

    Before surgery, 60 minutes after surgery and 24 hours after surgery

  • Postoperative complications

    5 days after surgery

Study Arms (1)

Lung ultrasound

Every patient will receive a chest RX and lung US

Device: Lung ultrasound

Interventions

Lung ultrasoundDEVICE

Lung ultrasound and chest RX

Lung ultrasound

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Patients following Nuss procedure for PE repair at Giannina Gaslini Institute

You may not qualify if:

  • absence of informed consent from parents
  • poor quality of the pre-operatory acoustic window

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Giannina Gaslini

Genova, Italy

Location

MeSH Terms

Conditions

Funnel Chest

Condition Hierarchy (Ancestors)

Bone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 20, 2017

First Posted

March 8, 2017

Study Start

April 1, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

August 7, 2019

Record last verified: 2019-08

Locations

IT(1)