An international prospective cohort study on spontaneous pneumothorax

Global assessment of spontaneous pneumothorax: outcomes and treatment

Registry ID
ISRCTN69084322
Source registry
ISRCTN
Status
Recruiting
Study type
OBSERVATIONAL
Sponsor
Azienda Ospedaliera Universitaria Integrata Verona
Enrollment
2000
Start date
2026-05-04
Completion date
2027-11-03
Last update
2026-08-17

Conditions

Summary

Spontaneous pneumothorax in pediatric and adult patients

Detailed description

This is a multicentre, international, prospective observational cohort study enrolling consecutive patients presenting with spontaneous pneumothorax. Clinical, imaging, and management data will be collected using standardized case report forms, with follow-up at 30 days and 12 months to record recurrence, complications, and outcomes. No interventions or additional tests are mandated beyond routine clinical care.

Interventions

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

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.

Locations

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