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Recruiting NCT03691480

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

No phase Interventional Pneumothorax, Spontaneous

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: simple exsufflation, Fuhrman catheter and ambulatory care.
Who it may be relevant to
Registry conditions: Pneumothorax, Spontaneous. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Procedure simple exsufflation
    simple exsufflation
  • Procedure Fuhrman catheter and ambulatory care
    Fuhrman catheter and ambulatory care

Primary outcome measures

  • Successful patient rates of ambulatory care [Time frame: Day 6]

Eligibility criteria

Inclusion criteria

  • Episode of primary spontaneous pneumothorax wide according to the criteria

Exclusion criteria

\-

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

France · 5 centers
  • CH Lorient — Lorient
  • CHU Rennes — Rennes
  • CH Sélestat — Sélestat
  • CH Saint-Malo — St-Malo
  • CHU Toulouse — Toulouse

Identifiers

NCT: NCT03691480 · 35RC17_8995_PNEUM-AMBU · 2019-A00085-52

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗