Clinical trial NCT06471608: Impact of Ambulatory Management for Primary Spontaneous Pneumothorax in the Emergency Department on Quality of Life
Official title: Impact of Ambulatory Management for Primary Spontaneous Pneumothorax in the Emergency Department on Quality of Life: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Primary Spontaneous Pneumothorax
Quality of Life
Ambulatory Care
Chest Tube
Keywords: Chest tube drainage
Primary spontaneous pneumothorax
Ambulatory management
Quality of life
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 387
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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 clinical trial or in a period of exclusion linked to previous participation in a clinical trial

Primary outcomes:
measure: Quality of life at 6 months
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
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