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

Pneumothorax, Spontaneous Clinical Trial

— PNEUM-AMBU  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03691480
• Other study ID #: 35RC17_8995_PNEUM-AMBU
• Status: Recruiting
• Phase: N/A
• Start date: September 17, 2021
• Est. completion date: September 17, 2025

Study information

• Verified date: June 2023
• Source: Rennes University Hospital
• Contact: Nicolas Mevel
• Phone: 02 99 28 25 55
• Email: dri[@]chu-rennes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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:

-

Related Conditions & MeSH terms

• Pneumothorax
• Pneumothorax, Spontaneous

Intervention

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

Locations

Country	Name	City	State
France	CH Lorient	Lorient
France	CHU Rennes	Rennes
France	CH Saint-Malo	Saint-Malo

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful patient rates of ambulatory care		Day 6