Spontaneous Pneumothorax in Children (NCT02573285) | Clinical Trial Compass
CompletedNot Applicable
Spontaneous Pneumothorax in Children
United States37 participantsStarted 2016-03-10
Plain-language 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.
Who can participate
Age range12 Years – 17 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
The success rate of simple aspiration of initial management of primary spontaneous pneumothorax in children
Timeframe: At the time of post-procedure chest X-ray