NCT02573285

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 9, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

March 10, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2018

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

December 5, 2019

Status Verified

December 1, 2019

Enrollment Period

2.2 years

First QC Date

October 5, 2015

Last Update Submit

December 4, 2019

Conditions

Spontaneous Pneumothorax

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Rate of recurrent pneumothorax

    After 6 hours of observation from treatment to 1 year

  • Time to recurrence of pneumothorax

    From initial treatment up one year

  • Total length of hospital stay

    Up to 7 days

  • Need for operative intervention (VATS) following initial management

    Up to 1 year

  • Number of chest X-rays and/or CT scans

    Up to 7 days

  • +3 more secondary outcomes

Study Arms (2)

Simple Aspiration

ACTIVE COMPARATOR

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

Surgeon Preference

ACTIVE COMPARATOR

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

Interventions

Simple AspirationPROCEDURE

Aspiration of pneumothorax with a small-bore catheter

Also known as: Thoracentesis
Simple Aspiration
Surgeon PreferencePROCEDURE

Any standard treatment option may be utilized for the treatment of the pneumothorax, including simple aspiration, chest tube placement, or an operation (VATS).

Surgeon Preference

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American Family Children's Hospital

Madison, Wisconsin, 53792, United States

Location

Related Publications (7)

  • 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;119(2):590-602. doi: 10.1378/chest.119.2.590.

    PMID: 11171742RESULT

  • 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. No abstract available.

    PMID: 20696690RESULT

  • 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(9):1240-4. doi: 10.1164/rccm.200111-078OC.

    PMID: 11991872RESULT

  • 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.

    PMID: 19651381RESULT

  • Sahn SA, Heffner JE. Spontaneous pneumothorax. N Engl J Med. 2000 Mar 23;342(12):868-74. doi: 10.1056/NEJM200003233421207. No abstract available.

    PMID: 10727592RESULT

  • Gupta D, Hansell A, Nichols T, Duong T, Ayres JG, Strachan D. Epidemiology of pneumothorax in England. Thorax. 2000 Aug;55(8):666-71. doi: 10.1136/thorax.55.8.666.

    PMID: 10899243RESULT

  • 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. doi: 10.1002/14651858.CD004479.pub2.

    PMID: 17253510RESULT

MeSH Terms

Conditions

Pneumothorax

Interventions

Thoracentesis

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ParacentesisSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesTherapeuticsSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Charles Leys, MD, MSCI

    Pediatric Surgeon, American Family Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2015

First Posted

October 9, 2015

Study Start

March 10, 2016

Primary Completion

June 4, 2018

Study Completion

November 1, 2019

Last Updated

December 5, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

No sharing

Locations

US(1)