Outpatient Management of Primary Spontaneous Pneumothorax: Pigtail Catheter With Unidirectional Valve vs. Exsufflation, Randomized Prospective Study (PNEUM-AMBU)

September 20, 2024 updated by: Rennes University Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

188

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Lorient, France
        • Recruiting
        • CH Lorient
        • Principal Investigator:
          • Laurent SOHIER
      • Rennes, France
        • Recruiting
        • CHU Rennes
        • Principal Investigator:
          • Stephane JOUNEAU
      • Saint-Malo, France
        • Recruiting
        • CH Saint-Malo
        • Principal Investigator:
          • Yann BAZIN
      • Sélestat, France
        • Not yet recruiting
        • CH Sélestat
        • Principal Investigator:
          • Mathieu OBERLIN
      • Toulouse, France
        • Not yet recruiting
        • CHU Toulouse
        • Principal Investigator:
          • Elise NOEL-SAVINA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Episode of primary spontaneous pneumothorax wide according to the criteria

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: simple exsufflation
Procedure: simple exsufflation
simple exsufflation
Experimental: Fuhrman catheter and ambulatory care
Procedure: Fuhrman catheter and ambulatory care
Fuhrman catheter and ambulatory care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Successful patient rates of ambulatory care
Time Frame: Day 6
Day 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Investigators

  • Principal Investigator: Stéphane Jouneau, CHU Rennes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2021

Primary Completion (Estimated)

September 23, 2026

Study Completion (Estimated)

September 17, 2027

Study Registration Dates

First Submitted

September 27, 2018

First Submitted That Met QC Criteria

September 28, 2018

First Posted (Actual)

October 1, 2018

Study Record Updates

Last Update Posted (Actual)

September 23, 2024

Last Update Submitted That Met QC Criteria

September 20, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35RC17_8995_PNEUM-AMBU
  • 2019-A00085-52 (Other Identifier: N°ID-RCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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