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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03691480
Acronym
PNEUM-AMBU
Enrollment
188
Registered
2018-10-01
Start date
2021-09-17
Completion date
2027-09-17
Last updated
2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumothorax, Spontaneous

Brief summary

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

PROCEDUREsimple exsufflation

simple exsufflation

PROCEDUREFuhrman catheter and ambulatory care

Fuhrman catheter and ambulatory care

Sponsors

Rennes University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* Episode of primary spontaneous pneumothorax wide according to the criteria

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frame
Successful patient rates of ambulatory careDay 6

Countries

France

Contacts

Primary ContactNicolas Mevel
dri@chu-rennes.fr02 99 28 25 55
Backup ContactAnne Ganivet
anne.ganivet@chu-rennes.fr02 99 28 25 55

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026