Clinical trial NCT03557320: Environmental Factor and Onset of Spontaneous Pneumothorax
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spontaneous Pneumothorax
Keywords: environment
pressure
temperature
case-crossover
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire de Saint Etienne
name: Centre Hospitalier Universitaire Dijon
name: Hopital Nord Franche-Comte
name: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
name: Centre Hospitalier de la Haute Saone
name: CHU de Reims
name: Centre Hospitalier de Bethune
name: Centre Hospitalier Saint Philibert Lomme
name: Centre Hospitalier de Roubaix
name: Boulogne sur Mer Hospital Center
name: Poitiers University Hospital
name: University Hospital, Clermont-Ferrand
name: Centre Hospitalier Universitaire de Angers
name: Centre Hospitalier Universitaire de Nīmes
First posted: 2018-06-15
Enrollment: 3090
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients were recruited in the emergency departments (ED) of fourteen French hospitals that are members of the EXPRED Network (EXPRED Study) (Desmettre et al. 2011) where emergency admission management software was available.

A search was performed of ED admissions databases to identify all patients with a primary diagnosis of pneumothorax (International Classification of Diseases (ICD) 10 code = J93) admitted between June 1, 2009 and May 31, 2013).

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Estimate odds ratio for the association between meteorological data and onset of PSP.
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Belfort
country: France
facility: Centre Hospitalier de Belfort
city: Boulogne sur Mer
country: France
facility: CH Boulogne sur Mer
city: Clermont Ferrand
country: France
facility: CHU Clermont Ferrand
city: Dijon
country: France
facility: CHU Dijon
city: Divion
country: France
facility: Polyclinique de DIVION
city: Henin Beaumont
country: France
facility: Clinique de HENIN BEAUMONT
city: Lomme
country: France
facility: CH Lomme
city: Mulhouse
country: France
facility: CH Mulhouse
city: Nimes
country: France
facility: CHU Nimes
city: Poitiers
country: France
facility: CHU Poitiers
city: Toulouse
country: France
facility: CHU Toulouse
city: Vesoul
country: France
facility: Centre Hospitalier de Vesoul
Study officials:
References: