Spontaneous Pneumothorax in Children
Completed · Not applicable
Conditions studied: Spontaneous Pneumothorax
In brief
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.
Key facts
- Study ID
- NCT02573285
- Run by
- University of Wisconsin, Madison
- People needed
- 37
- Starts
- 2016-03-10
- Expected to finish
- 2019-11-01
- Last updated by the study team
- 2019-12-05
Who can join
Age: 12 and older, up to 17. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Each subject must meet all of the following inclusion criteria to be enrolled in the study:
- Age greater than or equal to 12 years and less than 18 years at date of enrollment.
- First time seeking medical attention for symptoms related to primary spontaneous pneumothorax.
- Consulting surgeon determines that intervention is required for treatment of spontaneous pneumothorax.
You may not qualify if…
- Patients with a previous episode of pneumothorax on the same side of the chest that required medical treatment in the past.
- Pneumothorax is secondary to a co-morbid medical condition (underlying pulmonary disease, malignancy, or trauma).
- 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.
- Bilateral pneumothorax.
- Unstable patient in need of emergent intervention at surgeon discretion.
- Patients who are known to be pregnant.
- Patients in the custody of the state.
- Patients who are currently prisoners.
- Non-English speaking.
Where it is running
- American Family Children's Hospital — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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