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.
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
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
Parallel
Ambulatory management
Other intervention* Chest tube drainage in emergency department (Furhmann drain connected to Heimlich valve), connected to suction system at -5 to -10 cm H2O until bubbling stops * Follow-up imaging at 4 hours (chest X-ray or low-dose CT scan, depending on management practices in the centers) * if the pneumothorax is still very large, or if clinical tolerance is unsatisfactory (dyspnea, unrelieved pain, abnormal vital parameters), the patient should be admitted to hospital * if the lung is in the process of reattachment and a minimal detachment persists, and clinical tolerance is good (assessed on vital parameters, with oxygen saturation above 98%, good hemodynamic stability and pain relieved by analgesics), the patient may be discharged home.
Standard Care
Other interventionHospitalisation in a hospital department (pulmonology, thoracic surgery, short-stay emergency unit, critical care, according to the usual pathway of the center in which the patient is included). In-hospital monitoring until complete resolution of pneumothorax and drain removal (average 4-6 days).
Quality of life at 6 months
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, using the Short Form (36) Health Survey (The lower the score the more disability)
Success rate of the strategy as measured by pulmonary expansion (lung reattachment on X-ray / CT scan) the latest by the investigator who performed the drainage procedure
Proportion of patients having benefited from an exclusive outpatient management (patients not requiring hospitalisation during the ambulatory approach)
Assessment of Pain
Pain assessed on a numerical scale (rated from 0 to 10), 0 being the lowest pain and 10 being the maximum pain
Assessment of Dyspnea according to the mMRC classification
mMRC classification (0 to 4), 0 being no discomfort and 4 shortness of breath for simple acts of daily living.
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