Comparing two methods for managing spontaneous pneumothorax in outpatient settings
Outpatient Management of Primary Spontaneous Pneumothorax: Pigtail Catheter With Unidirectional Valve vs. Exsufflation, Randomized Prospective Study
NA · Rennes University Hospital · NCT03691480
This study is testing two different ways to treat a collapsed lung in outpatient settings to see which method works better for patients.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 188 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Rennes University Hospital (other) |
| Locations | 5 sites (Lorient and 4 other locations) |
| Trial ID | NCT03691480 on ClinicalTrials.gov |
What this trial studies
This study aims to compare two outpatient management techniques for primary spontaneous pneumothorax: the use of a pigtail catheter with a unidirectional valve versus simple exsufflation. Patients diagnosed with a large spontaneous pneumothorax will be randomly assigned to receive one of the two treatments. The study seeks to determine which method is more effective in managing the condition and reducing the need for further interventions. By evaluating patient outcomes, the research hopes to establish a more standardized approach to treating this condition.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals experiencing a primary spontaneous pneumothorax episode.
Not a fit: Patients with other types of pneumothorax or those requiring immediate invasive intervention may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients with spontaneous pneumothorax, potentially reducing hospital visits and enhancing recovery.
How similar studies have performed: While there is limited direct comparison of these two specific treatments, similar studies have shown varying success in managing pneumothorax with different approaches.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Episode of primary spontaneous pneumothorax wide according to the criteria Exclusion Criteria: \-
Where this trial is running
Lorient and 4 other locations
- CH Lorient — Lorient, France (RECRUITING)
- CHU Rennes — Rennes, France (RECRUITING)
- CH Sélestat — Sélestat, France (NOT_YET_RECRUITING)
- CH Saint-Malo — St-Malo, France (RECRUITING)
- CHU Toulouse — Toulouse, France (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Stéphane Jouneau — Rennes University Hospital
- Study coordinator: Nicolas Mevel
- Email: dri@chu-rennes.fr
- Phone: 02 99 28 25 55
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pneumothorax, Spontaneous