Simple Aspiration for Initial Management of Primary Spontaneous Pneumothorax in Children: A Multi-Center Pilot Study

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.