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

Not Applicable

Recruiting

• Conditions: Pneumothorax, Spontaneous
• Interventions: Procedure: Fuhrman catheter and ambulatory care; Procedure: simple exsufflation

• Registration Number: NCT03691480
• Lead Sponsor: Rennes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-27
• Study First Submitted QC: 2018-09-28
• Study First Posted: 2018-10-01
• Study Start: 2021-09-17
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-06
• Last Update Posted: 2023-06-07
• Primary Completion: 2024-09-23
• Study Completion: 2025-09-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 188

Inclusion Criteria

• Episode of primary spontaneous pneumothorax wide according to the criteria

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fuhrman catheter and ambulatory care	Fuhrman catheter and ambulatory care	-
simple exsufflation	simple exsufflation	-

Primary Outcome Measures

Name	Time	Method
Successful patient rates of ambulatory care	Day 6

Trial Locations

Locations (5)

CH Saint-Malo; 🇫🇷 Saint-Malo, France

CH Sélestat; 🇫🇷 Sélestat, France

CHU Toulouse; 🇫🇷 Toulouse, France

CH Lorient; 🇫🇷 Lorient, France

CHU Rennes; 🇫🇷 Rennes, France