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Outpatient Management of Primary Spontaneous Pneumothorax: Pigtail Catheter With Unidirectional Valve vs. Exsufflation, Randomized Prospective Study
Sponsor: Rennes University Hospital
Summary
The management of large spontaneous pneumothorax is not consensual. Current practice involves placement of a Fuhrman catheter connected to a one-way valve, with outpatient monitoring in pneumology consultation. Manual aspiration is a widely used alternative, but the two approaches have never been directly compared in a prospective study. The main objective of this randomized trial is to compare the efficacy of these two ambulatory strategies in adults with an episode of large unilateral primary spontaneous pneumothorax. We hypothesize that management with a Fuhrman catheter and one-way valve is superior to manual aspiration.
Key Details
Gender
All
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
148
Start Date
2021-09-17
Completion Date
2027-09-16
Last Updated
2026-10-22
Healthy Volunteers
No
Conditions
Interventions
Fuhrman catheter insertion
8.5 French Fuhrman catheter insertion using the Seldinger technique, connected to a three-way stopcock and a one-way valve
Three-way stopcock open
Opening of the three-way stopcock on Day 0 to connect the Fuhrman catheter to the one-way valve
Manual aspiration
Manual aspiration through the Fuhrman catheter with a 50 mL syringe through the Fuhrman catheter on Day 0, followed by closure of the three-way stopcock (optional second aspiration).
Locations (5)
Centre 02 - Groupe Hospitalier de Bretagne Sud, Hôpital du Scorff
Lorient, France
Centre 01 - CHU de RENNES, Hôpital Pontchaillou
Rennes, France
Centre 04 - GHSO, CH Selestat
Sélestat, France
Centre 03 - GHRE, CH Saint-Malo
St-Malo, France
Centre 05 - CHU Toulouse, Hôpital Larrey
Toulouse, France