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Spontaneous Pneumothorax in Children

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: NCT02573285
Recruitment Status : Completed
First Posted : October 9, 2015
Last Update Posted : December 5, 2019
Sponsor:
Collaborators:
Children's Hospital Medical Center, Cincinnati
Indiana University
Medical College of Wisconsin
Northwestern University
Nationwide Children's Hospital
University of Chicago
University of Louisville
University of Michigan
Washington University School of Medicine
Children's Mercy Hospital Kansas City
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.


Condition or disease Intervention/treatment Phase
Spontaneous Pneumothorax Procedure: Simple Aspiration Procedure: Surgeon Preference Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Simple Aspiration for Initial Management of Primary Spontaneous Pneumothorax in Children: A Multi-Center Pilot Study
Actual Study Start Date : March 10, 2016
Actual Primary Completion Date : June 4, 2018
Actual Study Completion Date : November 1, 2019


Arm Intervention/treatment
Active Comparator: Simple Aspiration
Subjects in this arm will undergo initial management of their pneumothorax with a simple aspiration procedure. The procedure will involve placement of a small catheter into the chest cavity and applying negative pressure to manually aspirate the air out of the chest cavity, which will allow the lung to re-expand.
Procedure: Simple Aspiration
Aspiration of pneumothorax with a small-bore catheter
Other Name: Thoracentesis

Active Comparator: Surgeon Preference
Subjects that choose the surgeon preference arm of the study are enrolling for prospective data collection only. These subjects will not have any portion their care directed by the study protocol. The decision to proceed with any treatment or intervention will be made jointly by the surgeon and the patient and his or her legal guardian. Any standard treatment option may be utilized, including simple aspiration, chest tube placement, or an operation (VATS).
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).




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Rate of recurrent pneumothorax [ Time Frame: After 6 hours of observation from treatment to 1 year ]
    Number of recurrent pneumothoraces

  2. 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

  3. Total length of hospital stay [ Time Frame: Up to 7 days ]
    Time between admission until discharge for treatment of pneumothorax

  4. Need for operative intervention (VATS) following initial management [ Time Frame: Up to 1 year ]
    Surgical intervention needed for pneumothorax (yes/no)

  5. 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

  6. Procedural complications [ Time Frame: Up to 7 days ]
    Count of the number of complications during the initial hospitalization for pneumothorax

  7. Total aggregate hospital costs for initial hospitalization [ Time Frame: Up to 7 days ]
    Aggregate hospital charges during initial admission for pneumothorax

  8. Need for further intervention for spontaneous pneumothorax [ Time Frame: Between 1 year and 5 year follow-up ]
    Treatment or intervention needed for spontaneous pneumothorax after the 1 year follow-up



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Each subject must meet all of the following inclusion criteria to be enrolled in the study:

  1. Age greater than or equal to 12 years and less than 18 years at date of enrollment.
  2. First time seeking medical attention for symptoms related to primary spontaneous pneumothorax.
  3. Consulting surgeon determines that intervention is required for treatment of spontaneous pneumothorax.

Exclusion Criteria:

  1. Patients with a previous episode of pneumothorax on the same side of the chest that required medical treatment in the past.
  2. Pneumothorax is secondary to a co-morbid medical condition (underlying pulmonary disease, malignancy, or trauma).
  3. Pneumothorax is small and amenable to observation: size <2cm space between lung and chest wall at the apex and clinically stable patient with minimal symptoms.
  4. Bilateral pneumothorax.
  5. Unstable patient in need of emergent intervention at surgeon discretion.
  6. Patients who are known to be pregnant.
  7. Patients in the custody of the state.
  8. Patients who are currently prisoners.
  9. Non-English speaking.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02573285


Locations
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United States, Wisconsin
American Family Children's Hospital
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Children's Hospital Medical Center, Cincinnati
Indiana University
Medical College of Wisconsin
Northwestern University
Nationwide Children's Hospital
University of Chicago
University of Louisville
University of Michigan
Washington University School of Medicine
Children's Mercy Hospital Kansas City
Investigators
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Principal Investigator: Charles Leys, MD, MSCI Pediatric Surgeon, American Family Children's Hospital
Publications of Results:
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT02573285    
Other Study ID Numbers: 2014-1188
A539790 ( Other Identifier: UW, Madison )
SMPH/SURGERY ( Other Identifier: UW, Madison )
First Posted: October 9, 2015    Key Record Dates
Last Update Posted: December 5, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No sharing

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumothorax
Pleural Diseases
Respiratory Tract Diseases