Spontaneous pneumothorax in pediatric and adult patients Respiratory
Conditions
Interventions
This is a multicentre, international, prospective observational cohort study enrolling consecutive patients presenting with spontaneous pneumothorax. Clinical, imaging, and management data will be col
Sponsors
Azienda Ospedaliera Universitaria Integrata Verona
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients of any sex aged under 18 years (pediatric) or 18 years and older (adult) 2. Presentation to a participating hospital with spontaneous pneumothorax (primary or secondary) 3. Index management episode (observation, aspiration, drainage, ambulatory device, or surgery) initiated at the participating site during the data collection window 4. Ability to follow up through medical records or clinical contact at 30 days and 12 months
Exclusion criteria
Exclusion criteria: 1. Traumatic pneumothorax resulting from blunt or penetrating chest injury. 2. Iatrogenic pneumothorax clearly related to medical or surgical procedures (e.g., central venous catheter insertion, thoracic surgery, pleural biopsy, barotrauma from mechanical ventilation), unless treated as spontaneous by the clinical team. 3. Perioperative or intraoperative pneumothorax occurring as an intended event during thoracic surgery. 4. Duplicate entries for the same clinical episode. 5. Patients for whom essential data on presentation or management cannot be obtained from medical records.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adherence to international evidence-based audit standards for the management of spontaneous pneumothorax, measured using a predefined checklist of guideline-derived criteria recorded at the time of index presentation and initial management. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Initial management strategy (observation, aspiration, drainage, ambulatory device, surgery) measured using standardized case report form (CRF) data at the time of index presentation. 2. Persistent air leak measured by clinical observation and documentation of ongoing bubbling >48–72 hours after intervention during index admission. 3. Complications (infection, bleeding, re-expansion pulmonary edema, device displacement) measured using CRF documentation during index admission and at 30-day follow-up. 4. Length of hospital stay measured in days from admission to discharge for the index episode. 5. Recurrence rate (ipsilateral or contralateral) measured by clinical or radiologic confirmation at 30-day and 12-month follow-up. 6. Need for definitive surgical intervention (e.g., VATS, pleurodesis, thoracotomy) recorded from CRF data within 12 months after index presentation. 7. Predictors of non-adherence and adverse outcomes (age, comorbidity, genetic syndromes, resource setting) analyzed using multivariable modeling from data collected at baseline and follow-up. 8. Functional recovery (return to school/work/sport) assessed at 12-month follow-up via patient record or reported data when available. | — |
Countries
Austria, Czech Republic, France, Germany, Italy, Spain, Sweden, Türkiye
Contacts
Public ContactFederica Pederiva
Outcome results
None listed