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.

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Key information

Conditions

Pneumothorax, Spontaneous Pleural Diseases Pneumothorax Respiratory Tract Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH Lorient, Lorient, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Episode of primary spontaneous pneumothorax wide according to the criteria

Exclusion criteria

Treatment and study plan

simple exsufflation

Procedure

simple exsufflation

Fuhrman catheter and ambulatory care

Procedure

Fuhrman catheter and ambulatory care

Primary outcomes

Successful patient rates of ambulatory care

Time frame: Day 6

Study contacts

Contact information is provided by the study sponsor or research team.

Anne Ganivet

CONTACT

[email protected]

02 99 28 25 55

Nicolas Mevel

CONTACT

[email protected]

02 99 28 25 55

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: PNEUM-AMBU

Important dates

Study start: 2021
Primary completion: 2026
Study completion: 2027
First posted: Oct 1, 2018
Registry last updated: Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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