Outpatient Management of Primary Spontaneous Pneumothorax: Pigtail Catheter With Unidirectional Valve vs. Exsufflation, Randomized Prospective Study (PNEUM-AMBU)

Rennes University Hospital

Status: Enrolling

Conditions: Pneumothorax, Spontaneous

Treatments: Procedure: simple exsufflation; Procedure: Fuhrman catheter and ambulatory care

Study type: Interventional

Funder types: Other

Identifiers

NCT03691480

2019-A00085-52 (Other Identifier)

35RC17_8995_PNEUM-AMBU

Details and patient eligibility

About

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.

Enrollment: 188 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Episode of primary spontaneous pneumothorax wide according to the criteria

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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188 participants in 2 patient groups

simple exsufflation

Experimental group

Treatment:

Procedure: simple exsufflation

Fuhrman catheter and ambulatory care

Experimental group

Treatment:

Procedure: Fuhrman catheter and ambulatory care