Outpatient Management of Primary Spontaneous Pneumothorax: Pigtail Catheter With Unidirectional Valve vs. Exsufflation, Randomized Prospective Study
PNEUM-AMBU
2 other identifiers
interventional
188
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2021
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2018
CompletedFirst Posted
Study publicly available on registry
October 1, 2018
CompletedStudy Start
First participant enrolled
September 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 23, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 17, 2027
September 23, 2024
September 1, 2024
5 years
September 27, 2018
September 20, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Successful patient rates of ambulatory care
Day 6
Study Arms (2)
simple exsufflation
EXPERIMENTALFuhrman catheter and ambulatory care
EXPERIMENTALInterventions
Fuhrman catheter and ambulatory care
Eligibility Criteria
You may qualify if:
- Episode of primary spontaneous pneumothorax wide according to the criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
CH Lorient
Lorient, France
CHU Rennes
Rennes, France
CH Sélestat
Sélestat, France
CH Saint-Malo
St-Malo, France
CHU Toulouse
Toulouse, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stéphane Jouneau
CHU Rennes
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2018
First Posted
October 1, 2018
Study Start
September 17, 2021
Primary Completion (Estimated)
September 23, 2026
Study Completion (Estimated)
September 17, 2027
Last Updated
September 23, 2024
Record last verified: 2024-09