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

NCT ID: NCT03691480

Last Updated: 2024-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-17

Study Completion Date

2027-09-17

Brief Summary

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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

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Conditions

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Pneumothorax, Spontaneous

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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simple exsufflation

Group Type EXPERIMENTAL

simple exsufflation

Intervention Type PROCEDURE

simple exsufflation

Fuhrman catheter and ambulatory care

Group Type EXPERIMENTAL

Fuhrman catheter and ambulatory care

Intervention Type PROCEDURE

Fuhrman catheter and ambulatory care

Interventions

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simple exsufflation

simple exsufflation

Intervention Type PROCEDURE

Fuhrman catheter and ambulatory care

Fuhrman catheter and ambulatory care

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Episode of primary spontaneous pneumothorax wide according to the criteria

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stéphane Jouneau

Role: PRINCIPAL_INVESTIGATOR

CHU Rennes

Locations

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CH Lorient

Lorient, , France

Site Status RECRUITING

CHU Rennes

Rennes, , France

Site Status RECRUITING

CH Sélestat

Sélestat, , France

Site Status NOT_YET_RECRUITING

CH Saint-Malo

St-Malo, , France

Site Status RECRUITING

CHU Toulouse

Toulouse, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Nicolas Mevel

Role: CONTACT

02 99 28 25 55

Anne Ganivet

Role: CONTACT

02 99 28 25 55

Other Identifiers

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2019-A00085-52

Identifier Type: OTHER

Identifier Source: secondary_id

35RC17_8995_PNEUM-AMBU

Identifier Type: -

Identifier Source: org_study_id

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