Environmental Factor and Onset of Spontaneous Pneumothorax

Spontaneous Pneumothorax Clinical Trial

— EXPPO  

Official title:

Impact of Meteorological Conditions on the Onset of First Episod of Spontaneous Pneumothorax : a French Multicenter Case-crosserover Study About 945 Subjects in 14 Centers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03557320
• Other study ID #: API/2012/29
• Status: Completed
• Start date: May 31, 2013
• Est. completion date: June 30, 2014

Study information

• Verified date: January 2020
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3090
• Est. completion date: June 30, 2014
• Est. primary completion date: June 30, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Pneumothorax
• Spontaneous Pneumothorax

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	Centre Hospitalier de Belfort	Belfort
France	CH Boulogne sur Mer	Boulogne sur Mer
France	CHU Clermont Ferrand	Clermont Ferrand
France	CHU Dijon	Dijon
France	Polyclinique de DIVION	Divion
France	Clinique de HENIN BEAUMONT	Henin Beaumont
France	CH Lomme	Lomme
France	CH Mulhouse	Mulhouse
France	CHU Nimes	Nimes
France	CHU Poitiers	Poitiers
France	CHU Toulouse	Toulouse
France	Centre Hospitalier de Vesoul	Vesoul

Sponsors (15)

Lead Sponsor

Collaborator

Centre Hospitalier Universitaire de Besancon

Centre Hospitalier de Bethune, Centre Hospitalier de Boulogne sur Mer, Centre Hospitalier de la Haute Saone, Centre Hospitalier de Roubaix, Centre Hospitalier Saint Philibert Lomme, Centre Hospitalier Universitaire de Angers, Centre Hospitalier Universitaire de Nimes, Centre Hospitalier Universitaire de Saint Etienne, Centre Hospitalier Universitaire Dijon, CHU de Reims, Groupe Hospitalier de la Region de Mulhouse et Sud Alsace, Hôpital Nord Franche-Comté, Poitiers University Hospital, University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimate odds ratio for the association between meteorological data and onset of PSP.		28 days