Impact of Ambulatory Management for Primary Spontaneous Pneumothorax in the Emergency Department … (NCT06471608) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Impact of Ambulatory Management for Primary Spontaneous Pneumothorax in the Emergency Department on Quality of Life
France386 participantsStarted 2025-12-01
Plain-language summary
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.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion Criteria:
* 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
* Patient affiliated to or benefiting from a social health insurance
Exclusion Criteria:
* 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
* Secondary spontaneous pneumothorax
* Bilateral pneumothorax
* Associated fluid effusion
* Risk-benefit balance unfavorable to outpatient treatment (comorbidities, isolated patient, difficulty understanding monitoring instructions)
* Patient living more than one hour from hospital
* Patients living alone or unable to be accompanied on discharge for the first 48 hours
* Patients under legal protection
* Pregnant or breast-feeding women
* Patient participating in a therapeutic interventional…