About this trial

Outpatient treatment of Primary Spontaneous Pneumothorax (PSP) compared to usual inpatient management could improve quality of care and represent a more efficient, generalizable and sustainable strategy.

This multicenter, cluster-controlled, randomized interventional study with stepped wedge implementation will evaluate the impact on quality of life (between inclusion, after drain placement, and 6 months) of an ambulatory strategy for the management of large abundance primary spontaneous pneumothorax in the emergency department, compared with usual care.

Eligibility criteria

Qualifiers

Patients aged 18 to 50 years presenting to the emergency department with a 1st episode of right or left primary spontaneous pneumothorax (PSP) of large abundance diagnosed by chest X-ray or CT scan defined according to British Thoracic Society (BTS) recommendations as a detachment greater than 2 cm over the entire height of the axillary line.

Patient living less than an hour from hospital and able to be accompanied for the first 48 hours

Patient able to understand the aims and risks of the research and to give informed, dated and signed consent

Patient with Internet access and able to complete online questionnaires

Disqualifiers

Small pneumothorax (≤ 2cm)

Suffocating pneumothorax defined by the presence of signs of respiratory distress or hemodynamic failure with indication for emergency exsufflation

Patient on emergency oxygen or long-term oxygen therapy

Traumatic pneumothorax

Trial design

Treatments tested in this trial

  • Ambulatory management
  • Standard Care

Treatment groups

386 Participants
are divided into 2 treatment groups

Locations

7
CHRU de Besançon - Hôpital Jean Minjoz25030, Besançon France
Hôpital Pellegrin - CHU de Bordeaux33000, Bordeaux France
CHU de Grenoble - Hôpital Michallon38700, La Tronche France
Hôpital Saint Louis - AP-HP75475, Paris France

Sponsors and collaborators

University Hospital, Strasbourg, France

Lead sponsor