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Impact of Ambulatory Management for Primary Spontaneous Pneumothorax in the Emergency Department on Quality of Life
Sponsor: University Hospital, Strasbourg, France
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.
Official title: Impact of Ambulatory Management for Primary Spontaneous Pneumothorax in the Emergency Department on Quality of Life: a Randomized Clinical Trial
Key Details
Gender
All
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
386
Start Date
2025-12-01
Completion Date
2030-07
Last Updated
2025-11-26
Healthy Volunteers
No
Interventions
Ambulatory management
* 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
Hospitalisation 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).
Locations (7)
CHRU de Besançon - Hôpital Jean Minjoz
Besançon, France
Hôpital Pellegrin - CHU de Bordeaux
Bordeaux, France
CHU de Grenoble - Hôpital Michallon
La Tronche, France
Hôpital Saint Louis - AP-HP
Paris, France
Hôpital Universitaire Pitié Salpétrière AP-HP
Paris, France
Hôpital de la Milétrie - CHU de Poitiers
Poitiers, France
Hôpitaux Universitaires de Strasbourg
Strasbourg, France