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NCT03691480: PNEUM-AMBU

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

Recruiting now NA Last updated 23 September 2024
What this trial tests

NA trial testing simple exsufflation in Pneumothorax, Spontaneous in 188 participants. Currently enrolling.

Timeline
17 September 2021
Primary endpoint
23 September 2026
17 September 2027

Quick facts

Lead sponsorRennes University Hospital
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment188
Start date17 September 2021
Primary completion23 September 2026
Estimated completion17 September 2027
Sites5 locations across France

Drugs / interventions tested

Conditions studied

Sponsor

Rennes University Hospital

Who can join

Adults 18 to 50, any sex, with Pneumothorax, Spontaneous. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The management of spontaneous large pneumothorax is not consensual. The current management involves the establishment of a Fuhrman catheter and an outpatient monitoring in pneumology consultation. Another alternative is widespread: simple exsufflation. However, no study has looked at the direct prospective comparison of these 2 treatments.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. SPLF/SMFU/SRLF/SFAR/SFCTCV Guidelines for the management of patients with primary spontaneous pneumothorax.
    Jouneau S, Ricard JD, Seguin-Givelet A, Bigé N, et al · · 2023 · cited 16× · PMID 37725198 · DOI 10.1186/s13613-023-01181-2

Verify or expand the search:

Other recruiting trials for Pneumothorax, Spontaneous

Currently open trials in the same condition.

Other Rennes University Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03691480.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing