Environmental Factor and Onset of Spontaneous Pneumothorax

Completed

• Conditions: Spontaneous Pneumothorax

• Registration Number: NCT03557320
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief Summary

The study aims to evaluate the association between spontaneous pneumothorax onset and weather parameters.

Detailed Description

The aim of this study is to analyse the relation between onset of the PSP and exposure to environmental factors such as atmospheric pressure.

A case-crossover epidemiological study will be conducted in 14 French hospitals. SP recorded from 2009 to 2013 will be exhaustively included. Demographic and clinical characteristics will be collected. For each incident case of SP, the period of occurrence of the event (case period) will be compared to several other periods temporally distant from the case period (control periods prior to and after the event). Exposure will be assessed using meteorological stations localized in the vicinity of each patient's home. A potential threshold effect and/or time lag effect between exposure and admission for SP will be explored.

The results of this study will help to identify the meteorological factors associated with the occurrence of SP, and to deepen our knowledge of the pathophysiological mechanisms of SP especially the influence of meteorological factors on bleb rupture.

Study Timeline

• Study Start: 2013-05-31
• Primary Completion: 2014-06-30
• Study Completion: 2014-06-30
• Study First Submitted: 2016-09-05
• Study First Submitted QC: 2018-06-04
• Study First Posted: 2018-06-15
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-24
• Last Update Posted: 2020-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3090

Inclusion Criteria

• age over 18 years
• first episode of primary spontaneous pneumothorax

Exclusion Criteria

• Patients with traumatic
• Patients with secondary pneumothorax
• Patients with recurrent pneumothorax and patients with short-term readmissions (recurrence was defined as a new ED admission for the same diagnosis more than 14 days after the first admission).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Estimate odds ratio for the association between meteorological data and onset of PSP.	28 days

Trial Locations

Locations (13)

CHU Nimes; 🇫🇷 Nimes, France

Clinique de HENIN BEAUMONT; 🇫🇷 Henin Beaumont, France

Polyclinique de DIVION; 🇫🇷 Divion, France

CHU Dijon; 🇫🇷 Dijon, France

CHU Toulouse; 🇫🇷 Toulouse, France

CHU Angers; 🇫🇷 Angers, France

CH Boulogne sur Mer; 🇫🇷 Boulogne sur Mer, France

CHU Clermont Ferrand; 🇫🇷 Clermont Ferrand, France

Centre Hospitalier de Belfort; 🇫🇷 Belfort, France

CH Lomme; 🇫🇷 Lomme, France

CH Mulhouse; 🇫🇷 Mulhouse, France

CHU Poitiers; 🇫🇷 Poitiers, France

Centre Hospitalier de Vesoul; 🇫🇷 Vesoul, France