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Clinical Trials in France / NCT06471608
Starting soon Not applicable

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

NCT06471608 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Strasbourg, France
Phase
Not applicable
Started
2025-12-01
Last updated
2025-11-26

Condition(s) studied

Primary Spontaneous PneumothoraxQuality of LifeAmbulatory CareChest Tube

Investigational drug(s) / intervention(s)

Ambulatory managementStandard Care

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).

Study 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

Sex
ALL
Min age
18 Years
Max age
50 Years
Healthy volunteers
No
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 outcome measure(s)

Trial sites (7)

FacilityCityRegionStatus
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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06471608 on ClinicalTrials.gov ↗ ← All trials in France