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Spontaneous Pneumothorax in Children

NCT02573285 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2019-12-05

No results posted yet for this study

Summary

The objective of this multi-center, non-randomized, prospective pilot study is to examine the rate of successful primary spontaneous pneumothorax (PSP) resolution using the simple aspiration technique.

In this study, eligible subjects diagnosed with PSP at eleven participating large children's hospitals (members of the Midwest Pediatric Surgical Clinical Research Consortium) will be enrolled and offered a choice of management with either the simple aspiration protocol or management according to their surgeon's preference, which may include simple aspiration, chest tube placement, or rarely, an operation.

Conditions

  • Spontaneous Pneumothorax

Interventions

PROCEDURE

Simple Aspiration

Aspiration of pneumothorax with a small-bore catheter

PROCEDURE

Surgeon Preference

Any standard treatment option may be utilized for the treatment of the pneumothorax, including simple aspiration, chest tube placement, or an operation (VATS).

Sponsors & Collaborators

  • Children's Hospital Medical Center, Cincinnati

    collaborator OTHER

  • Indiana University

    collaborator OTHER

  • Medical College of Wisconsin

    collaborator OTHER

  • Northwestern University

    collaborator OTHER

  • Nationwide Children's Hospital

    collaborator OTHER

  • University of Chicago

    collaborator OTHER

  • University of Louisville

    collaborator OTHER

  • University of Michigan

    collaborator OTHER

  • Washington University School of Medicine

    collaborator OTHER

  • Children's Mercy Hospital Kansas City

    collaborator OTHER

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Charles Leys, MD, MSCI · Pediatric Surgeon, American Family Children's Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-10
Primary Completion
2018-06-04
Completion
2019-11-01

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02573285 on ClinicalTrials.gov