Spontaneous Pneumothorax Clinical Trial
Official title:
Simple Aspiration for Initial Management of Primary Spontaneous Pneumothorax in Children: A Multi-Center Pilot Study
Verified date | December 2019 |
Source | University of Wisconsin, Madison |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 37 |
Est. completion date | November 1, 2019 |
Est. primary completion date | June 4, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Years to 17 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | American Family Children's Hospital | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
University of Wisconsin, Madison | Children's Hospital Medical Center, Cincinnati, Children's Mercy Hospital Kansas City, Indiana University, Medical College of Wisconsin, Nationwide Children's Hospital, Northwestern University, University of Chicago, University of Louisville, University of Michigan, Washington University School of Medicine |
United States,
Baumann MH, Strange C, Heffner JE, Light R, Kirby TJ, Klein J, Luketich JD, Panacek EA, Sahn SA; AACP Pneumothorax Consensus Group. Management of spontaneous pneumothorax: an American College of Chest Physicians Delphi consensus statement. Chest. 2001 Feb — View Citation
Gupta D, Hansell A, Nichols T, Duong T, Ayres JG, Strachan D. Epidemiology of pneumothorax in England. Thorax. 2000 Aug;55(8):666-71. — View Citation
MacDuff A, Arnold A, Harvey J; BTS Pleural Disease Guideline Group. Management of spontaneous pneumothorax: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii18-31. doi: 10.1136/thx.2010.136986. — View Citation
Noppen M, Alexander P, Driesen P, Slabbynck H, Verstraeten A. Manual aspiration versus chest tube drainage in first episodes of primary spontaneous pneumothorax: a multicenter, prospective, randomized pilot study. Am J Respir Crit Care Med. 2002 May 1;165 — View Citation
Robinson PD, Cooper P, Ranganathan SC. Evidence-based management of paediatric primary spontaneous pneumothorax. Paediatr Respir Rev. 2009 Sep;10(3):110-7; quiz 117. doi: 10.1016/j.prrv.2008.12.003. Epub 2009 May 21. Review. — View Citation
Sahn SA, Heffner JE. Spontaneous pneumothorax. N Engl J Med. 2000 Mar 23;342(12):868-74. Review. — View Citation
Wakai A, O'Sullivan RG, McCabe G. Simple aspiration versus intercostal tube drainage for primary spontaneous pneumothorax in adults. Cochrane Database Syst Rev. 2007 Jan 24;(1):CD004479. Review. Update in: Cochrane Database Syst Rev. 2017 Sep 07;9:CD00447 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The success rate of simple aspiration of initial management of primary spontaneous pneumothorax in children | Adequate expansion of the lung without the need for additional intervention from admission until discharge for PSP | At the time of post-procedure chest X-ray | |
Secondary | Rate of recurrent pneumothorax | Number of recurrent pneumothoraces | After 6 hours of observation from treatment to 1 year | |
Secondary | Time to recurrence of pneumothorax | Recurrence of a pneumothorax within 1 year of initial hospitalization for pneumothorax | From initial treatment up one year | |
Secondary | Total length of hospital stay | Time between admission until discharge for treatment of pneumothorax | Up to 7 days | |
Secondary | Need for operative intervention (VATS) following initial management | Surgical intervention needed for pneumothorax (yes/no) | Up to 1 year | |
Secondary | Number of chest X-rays and/or CT scans | Count of the number of chest X-rays completed or CT scans completed for pneumothorax | Up to 7 days | |
Secondary | Procedural complications | Count of the number of complications during the initial hospitalization for pneumothorax | Up to 7 days | |
Secondary | Total aggregate hospital costs for initial hospitalization | Aggregate hospital charges during initial admission for pneumothorax | Up to 7 days | |
Secondary | Need for further intervention for spontaneous pneumothorax | Treatment or intervention needed for spontaneous pneumothorax after the 1 year follow-up | Between 1 year and 5 year follow-up |
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