Clinical Trial: Spontaneous Pneumothorax in Children

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Simple Aspiration for Initial Management of Primary Spontaneous Pneumothorax in Children: A Multi-Center Pilot Study

Brief 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.


Detailed Summary:

This is a prospective, non-randomized, multi-center pilot study involving children (age 12-17 years old) who present with a first episode of primary spontaneous pneumothorax (PSP) that requires treatment. Treatment with simple aspiration has been researched in adults but it has not been investigated in children. For this reason, this will be a pilot study design with two non-randomized groups. Since some pediatric surgeons have started to offer this treatment in children and some of the adult studies include adolescent patients, simple aspiration is considered a standard of care treatment at many institutions, and is performed as part of standard care at UW. Patient and Provider communication regarding treatment options and the Patient and Provider choice choice of treatment play a large role both in the standard of care for PSP and this research study.

Potential subjects will be identified by a consulting surgeon (who will be a study team member as all pediatric surgeons are on this application) when surgical consultation is requested for acute management of a child with spontaneous pneumothorax. This most commonly occurs in the emergency department after a chest X-ray is obtained as part of the usual evaluation for the associated symptoms of pain and shortness of breath. Medical records may be reviewed to confirm eligibility prior to approaching potential subjects and their parents/guardians for assent/consent. The consulting surgeon will also assess patient eligibility by screening for inclusion and exclusion criteria. If all eligibility criteria are met, the consulting surgeon will notify a member of the study staff about the potential subject.

A member of the research team will explain the study rationale and procedures in detail with potential subjects and their legal guardian upon surgical consultation. All written
Sponsor: University of Wisconsin, Madison

Current Primary Outcome: The success rate of simple aspiration of initial management of primary spontaneous pneumothorax in children [ Time Frame: At the time of post-procedure chest X-ray ]

Adequate expansion of the lung without the need for additional intervention from admission until discharge for PSP


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Rate of recurrent pneumothorax [ Time Frame: After 6 hours of observation from treatment to 1 year ]
    Number of recurrent pneumothoraces
  • Time to recurrence of pneumothorax [ Time Frame: From initial treatment up one year ]
    Recurrence of a pneumothorax within 1 year of initial hospitalization for pneumothorax
  • Total length of hospital stay [ Time Frame: Up to 7 days ]
    Time between admission until discharge for treatment of pneumothorax
  • Need for operative intervention (VATS) following initial management [ Time Frame: Up to 7 days ]
    Surgical intervention needed for pneumothorax (yes/no)
  • Number of chest X-rays and/or CT scans [ Time Frame: Up to 7 days ]
    Count of the number of chest X-rays completed or CT scans completed for pneumothorax
  • Procedural complications [ Time Frame: Up to 7 days ]
    Count of the number of complications during the initial hospitalization for pneumothorax
  • Total aggregate hospital costs for initial hospitalization [ Time Frame: Up to 7 days ]
    Aggregate hospital charges during initial admission for pneumothorax


Original Secondary Outcome: Same as current

Information By: University of Wisconsin, Madison

Dates:
Date Received: October 5, 2015
Date Started: September 2015
Date Completion: July 2019
Last Updated: May 1, 2017
Last Verified: May 2017