Spontaneous Pneumothorax in Children
|ClinicalTrials.gov Identifier: NCT02573285|
Recruitment Status : Completed
First Posted : October 9, 2015
Last Update Posted : December 5, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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).
- 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
- 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 1 year ]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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02573285
|United States, Wisconsin|
|American Family Children's Hospital|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||Charles Leys, MD, MSCI||Pediatric Surgeon, American Family Children's Hospital|