Pneumothorax, Spontaneous Clinical Trial
— PNEUM-AMBUOfficial title:
Outpatient Management of Primary Spontaneous Pneumothorax: Pigtail Catheter With Unidirectional Valve vs. Exsufflation, Randomized Prospective Study
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.
| Status | Recruiting |
| Enrollment | 188 |
| Est. completion date | September 17, 2025 |
| Est. primary completion date | September 23, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 50 Years |
| Eligibility | Inclusion Criteria: - Episode of primary spontaneous pneumothorax wide according to the criteria Exclusion Criteria: - |
| Country | Name | City | State |
|---|---|---|---|
| France | CH Lorient | Lorient | |
| France | CHU Rennes | Rennes | |
| France | CH Saint-Malo | Saint-Malo |
| Lead Sponsor | Collaborator |
|---|---|
| Rennes University Hospital |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Successful patient rates of ambulatory care | Day 6 |
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