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ClinicalTrials.gov ID

NCT06471608

Lead Sponsor

University Hospital, Strasbourg, FranceOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

386Estimated

Last Update Posted

Nov 26, 2025Actual

Start Date

Dec 1, 2025Estimated

Primary Completion Date

Jul 1, 2030Estimated

Completion Date

Jul 2030Estimated

Official Title

Impact of Ambulatory Management for Primary Spontaneous Pneumothorax in the Emergency Department on Quality of Life: a Randomized Clinical Trial

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.

• Primary Spontaneous Pneumothorax
• Quality of Life
• Ambulatory Care
• Chest Tube

• Ambulatory management
• Standard Care

Ages Eligible for Study

Adult (18-64)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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 Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

University Hospital, Strasbourg, FranceOTHER

cedric.gil-jardine@chu-bordeaux.fr+33 5 56 79 56 79

DViglino@chu-grenoble.fr+33 4 76 76 54 32

olivier.peyrony@aphp.fr+33 1 42 49 49 49