GASPOUT study
The GASPOUT Project (Global Assessment of Spontaneous Pneumothorax: Outcomes and Treatment) is a prospective, multicentre, international observational study coordinated by the Pediatric Surgery Unit of the University Hospital of Verona and registered in the ISRCTN registry (ISRCTN69084322).
The study aims to evaluate, in a global cohort of pediatric (<18 years) and adult (≥18 years) patients, adherence to international guidelines for managing the first episode of spontaneous pneumothorax, while assessing variability in treatment strategies and clinical outcomes at 1 and 12 months. This is a non-interventional observational study that will not alter routine clinical practice.
Patient enrollment will begin on 4 May 2026 and proceed over predefined 2-week data collection periods across a total duration of 6 months, concluding on 15 November 2026.
No directly identifiable patient data will be entered into the central database. To allow follow-up at 30 days and 12 months, each participating centre will maintain a secure local linkage file mapping study IDs to patient identifiers, in accordance with local data protection regulations.
To participate, each site must designate a Hospital Lead who will complete the Registration Form.
REDCap database access will be granted exclusively to the Hospital Lead via the institutional or university email used during registration. The Hospital Lead is responsible for coordinating the local team and sharing access with collaborators involved in data collection.
While awaiting REDCap access, sites are encouraged to start data collection using the provided Case Report Form (CRF) and enter data into REDCap once access is granted.
Each participating hospital will form a local team of up to five collaborators per data collection period, responsible for patient inclusion, data entry, and follow-up. Teams may include junior doctors, residents, or medical students, supervised by up to two Consultant or Senior Leads (adult general/thoracic and/or pediatric surgeons).
An independent validator at each site will assess data completeness and accuracy over the 2-week collection period; this role will be recognised separately from the core team. All investigators contributing to patient identification, data collection, or validation will be acknowledged as PubMed-indexed collaborators under the group authorship “GASPOUT Collaborative.” Authorship will only be granted for datasets that are complete and meet predefined quality standards.
The Hospital Lead is responsible for maintaining a record of all collaborators and submitting final team details via a dedicated form at the study’s conclusion.
A formal Data Sharing Agreement (DSA) is not mandatory for participation in this observational study. However, upon request from participating institutions, a standard, non-negotiable DSA template can be provided
Federica Pederiva, MD PhD
GASPOUT PI and study coordinator
Pediatric Surgery
Azienda Ospedaliera Universitaria Integrata (AOUI) Verona, Verona, Italia
federica.pederiva@aovr.veneto.it
Please find below the documents required for submission to the local Ethics Committee.
Ethical Approval: Italian & English
Documents in Italian:
Informativa e consenso trattamento dati
Modulo consenso genitori-tutore legale
Modulo di consenso informato minore
Modulo di consenso informato minore maturo
Modulo consenso informato adulti
