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NOT YET RECRUITING
NCT06471608
NA

Impact of Ambulatory Management for Primary Spontaneous Pneumothorax in the Emergency Department on Quality of Life

Sponsor: University Hospital, Strasbourg, France

View on ClinicalTrials.gov

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

OTHER

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.

OTHER

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