Back to resultsOutpatient Management of Primary Spontaneous Pneumothorax: Pigtail Catheter With Unidirectional Valve vs. Exsufflation, Randomized Prospective Study (PNEUM-AMBU)
Primary Purpose
Pneumothorax, Spontaneous
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
simple exsufflation
Fuhrman catheter and ambulatory care
Sponsored by
About this trial
This is an interventional treatment trial for Pneumothorax, Spontaneous
Eligibility Criteria
Inclusion Criteria:
- Episode of primary spontaneous pneumothorax wide according to the criteria
Exclusion Criteria:
-
Sites / Locations
- CH LorientRecruiting
- CHU RennesRecruiting
- CH Saint-MaloRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
simple exsufflation
Fuhrman catheter and ambulatory care
Arm Description
Outcomes
Primary Outcome Measures
Successful patient rates of ambulatory care
Secondary Outcome Measures
Full Information
NCT ID
NCT03691480
First Posted
September 27, 2018
Last Updated
June 6, 2023
Sponsor
Rennes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03691480
Brief Title
Outpatient Management of Primary Spontaneous Pneumothorax: Pigtail Catheter With Unidirectional Valve vs. Exsufflation, Randomized Prospective Study
Acronym
PNEUM-AMBU
Official Title
Outpatient Management of Primary Spontaneous Pneumothorax: Pigtail Catheter With Unidirectional Valve vs. Exsufflation, Randomized Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 17, 2021 (Actual)
Primary Completion Date
September 23, 2024 (Anticipated)
Study Completion Date
September 17, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumothorax, Spontaneous
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
188 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
simple exsufflation
Arm Type
Experimental
Arm Title
Fuhrman catheter and ambulatory care
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
simple exsufflation
Intervention Description
simple exsufflation
Intervention Type
Procedure
Intervention Name(s)
Fuhrman catheter and ambulatory care
Intervention Description
Fuhrman catheter and ambulatory care
Primary Outcome Measure Information:
Title
Successful patient rates of ambulatory care
Time Frame
Day 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Episode of primary spontaneous pneumothorax wide according to the criteria
Exclusion Criteria:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas Mevel
Phone
02 99 28 25 55
Email
dri@chu-rennes.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Ganivet
Phone
02 99 28 25 55
Email
anne.ganivet@chu-rennes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stéphane Jouneau
Organizational Affiliation
CHU Rennes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH Lorient
City
Lorient
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent Sohier
Facility Name
CHU Rennes
City
Rennes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphane Jouneau
Facility Name
CH Saint-Malo
City
Saint-Malo
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yann Bazin
12. IPD Sharing Statement
Learn more about this trial
Outpatient Management of Primary Spontaneous Pneumothorax: Pigtail Catheter With Unidirectional Valve vs. Exsufflation, Randomized Prospective Study
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