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Clinical Trials in France / NCT03691480
Active, not recruiting Not applicable

Outpatient Management of Primary Spontaneous Pneumothorax: Pigtail Catheter With Unidirectional Valve vs. Exsufflation, Randomized Prospective Study

NCT03691480 · tracked via the Priya Life Science France tracker
Sponsor
Rennes University Hospital
Phase
Not applicable
Started
2021-09-17
Last updated
2026-10-22

Condition(s) studied

Pneumothorax Spontaneous Primary

Investigational drug(s) / intervention(s)

Fuhrman catheter insertionThree-way stopcock openManual aspiration

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).

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
50 Years
Healthy volunteers
No
* Inclusion Criteria : * Episode of large unilateral primary spontaneous pneumothorax according to British Thoracic Society (BTS), American College of Chest Physicians (ACCP) and/or French guidelines, defined as : a separation of ≥ 2 cm at the hilum, and/or ≥ 3 cm at the apex, and/or ≥ 2 cm over the whole height on an axillary view * Free and informed consent of the patient * Exclusion Criteria : * Impossibility of ambulatory management, at the clinician's discretion * Inability to follow or understand the study procedures * Secondary pneumothorax, i.e. associated with an underlying chronic respiratory disease such as chronic obstructive pulmonary disease (COPD), emphysema, asthma, cystic fibrosis or pulmonary fibrosis * Non-spontaneous pneumothorax: traumatic or iatrogenic * Protected persons: adults under legal protection (judicial protection, curatorship or guardianship), persons deprived of liberty, pregnant women (self-reported), breastfeeding women, and minors

Primary outcome measure(s)

  • Rate of successful ambulatory management — Day 6
    Success is assessed for each patient at Day 6 and is defined as complete or near-complete lung re-expansion on the Day 6 chest X-ray, without hospitalization decided by the treating physician and, in the manual aspiration arm, without change of arm (reopening of the circuit with connection of the one-way valve). Failure may occur earlier than Day 6: on Day 0 (Hour 0, Hour 4 or Hour 8) or Day 2 in the manual aspiration arm, and on Day 4 in the one-way valve arm. A patient switched from manual aspiration to the one-way valve is a failure even if the lung is re-expanded on Day 6. Pneumothorax thresholds are defined in the Detailed Description and Eligibility part.

Trial sites (5)

FacilityCityRegionStatus
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

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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 NCT03691480 on ClinicalTrials.gov ↗ ← All trials in France