Spontaneous Pneumothorax in Children

This is a prospective, non-randomized, multi-center pilot study involving children (age 12-17
years old) who present with a first episode of primary spontaneous pneumothorax (PSP) that
requires treatment. Treatment with simple aspiration has been researched in adults but it has
not been investigated in children. For this reason, this will be a pilot study design with
two non-randomized groups. Since some pediatric surgeons have started to offer this treatment
in children and some of the adult studies include adolescent patients, simple aspiration is
considered a standard of care treatment at many institutions, and is performed as part of
standard care at UW. Patient and Provider communication regarding treatment options and the
Patient and Provider choice choice of treatment play a large role both in the standard of
care for PSP and this research study.

Potential subjects will be identified by a consulting surgeon (who will be a study team
member as all pediatric surgeons are on this application) when surgical consultation is
requested for acute management of a child with spontaneous pneumothorax. This most commonly
occurs in the emergency department after a chest X-ray is obtained as part of the usual
evaluation for the associated symptoms of pain and shortness of breath. Medical records may
be reviewed to confirm eligibility prior to approaching potential subjects and their
parents/guardians for assent/consent. The consulting surgeon will also assess patient
eligibility by screening for inclusion and exclusion criteria. If all eligibility criteria
are met, the consulting surgeon will notify a member of the study staff about the potential
subject.

A member of the research team will explain the study rationale and procedures in detail with
potential subjects and their legal guardian upon surgical consultation. All written
information will be reviewed and all questions answered. A study physician will be available
at all times for any consent-related questions. The potential subject and legal guardian will
have up to one hour to consider if they would like to participate in the study. The child's
legal guardian will sign the informed consent, and the subject will sign assent.

Once consent/assent is obtained subjects and their parents/guardians will have the choice of
consenting to initial management with either the simple aspiration protocol (aspiration
group) or according to the preferences of the treating surgeon (preference group). All
patients will be properly informed of the options for each arm during the consent discussion,
most of the information is conveyed during the clinical treatment discussion with the
patients which is then incorporated into the consent discussion. Patient preference and
choice of treatment plays a large role in the standard of care methods for treating PSP and
subject preference and choice will play just as strong a role in this research study.

As a pilot study, we aim to enroll 32 subjects in the aspiration arm across all participating
institutions and 48 subjects will enroll into the preference arm. Since all medical
treatments performed during the study are considered standard of care, the only research
components of this study include the subject's self-allocation to a particular study arm
(even though patient choice is just as strong a role in standard of care, there are defined
arms for this research study) and the recording of medical and billing data for each subject,
as well as a follow-up phone call to the subject.

Aspiration Arm:

Subjects in this arm will undergo initial management of their pneumothorax with a simple
aspiration procedure according to standard care described here. 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.
The aspiration catheter will be less than or equal to 12 French in diameter. Further details
of the type of device and size of catheter will be determined by the surgeon and will depend
on the devices available for standard practice at each participating institution. The
procedure may be performed with local anesthetic, with or without sedation, depending on
surgeon judgment and available resources or standard practice at each participating
institution. The procedure may be performed with or without image guidance (i.e. ultrasound
or fluoroscopy) during the aspiration, but a chest X-ray must be obtained at the conclusion
of the procedure, with the catheter still in place, to verify successful expansion of the
lung and for comparison with subsequent chest X-rays. A small residual pneumothorax after the
initial aspiration procedure may still be deemed a success. Successful aspiration at the time
of the initial aspiration procedure will be defined as: expansion of the lung apex to the top
of the 4th rib or higher and expansion at the lateral chest wall to the 6th rib or higher. A
failure will be defined as a residual pneumothorax that is not limited to the apex and
extends laterally down the chest wall below the 6th rib. If the first post-procedure chest
X-ray demonstrates failure of adequate lung expansion, the existing catheter may be used for
one additional aspiration attempt, with application of negative pressure followed by another
chest X-ray.

After the aspiration procedure, the subject will be admitted to the hospital for a minimum
observation period of 6 hours. The small catheter will be capped and left in place and the
insertion site covered by an occlusive dressing, such that this same catheter could be
utilized in the event of failure of the aspiration procedure. After 6 hours, a second chest
X-ray will be obtained to assess for recurrent pneumothorax or enlargement of a small
residual pneumothorax. If the pneumothorax is stable or smaller in size after 6 hours of
observation, then the catheter will be removed and the patient discharged to home. However,
if the pneumothorax recurs or enlarges after 6 hours, then the aspiration procedure has
failed. The existing catheter could be uncapped and used as an indwelling chest tube for a
more prolonged period of chest drainage, but all management is according to the surgeon's
preference and standard practice. At any time, if the aspiration procedure is determined to
be a failure, by either inadequate lung expansion or recurrent pneumothorax, the patient will
be managed according to the judgment and standard practice of the treating surgeon.

Preference Arm:

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,
video-assisted thoracoscopic surgery (VATS). If the surgeon's preference and standard
treatment is simple aspiration but the patient does not want the aspiration procedure, then
the surgeon will perform an alternative treatment option, such as chest tube placement or
VATS.

Management strategies in the preference group may include placement of an indwelling chest
tube, with or without thoracoscopic resection of blebs (VATS), and may also include a simple
aspiration procedure if recommended by the treating surgeon.

For both arms, a telephone survey will be conducted at approximately one year from
enrollment. The primary purpose is to ascertain whether the subject has sought additional
medical treatment at another facility for unresolved or recurrent pneumothorax and time to
recurrence. Additionally, we wish to know if the subject has ongoing or intermittent episodes
of symptoms attributed to pneumothorax for which he/she has not sought medical treatment. A
yearly chart audit will continue for 5 additional years to determine if any further treatment
was needed for the initial pneumothorax.

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.