Environmental Factor and Onset of Spontaneous Pneumothorax (EXPPO)

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

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

Study Overview

• Status: Completed
• Conditions: Spontaneous Pneumothorax

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 Type: Observational
• Enrollment (Actual): 3090

Contacts and Locations

Study Locations

• France
  • Angers, France, 49100
    • CHU Angers
  • Belfort, France, 90016
    • Centre Hospitalier de Belfort
  • Boulogne sur Mer, France, 62320
    • CH Boulogne sur Mer
  • Clermont Ferrand, France, 63003
    • Chu Clermont Ferrand
  • Dijon, France, 21033
    • CHU Dijon
  • Divion, France, 62460
    • Polyclinique de DIVION
  • Henin Beaumont, France, 62110
    • Clinique de HENIN BEAUMONT
  • Lomme, France, 59160
    • CH Lomme
  • Mulhouse, France, 68051
    • CH Mulhouse
  • Nimes, France, 30029
    • CHU Nimes
  • Poitiers, France, 86000
    • CHU Poitiers
  • Toulouse, France, 31059
    • CHU Toulouse
  • Vesoul, France, 70000
    • Centre Hospitalier de Vesoul

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Estimate odds ratio for the association between meteorological data and onset of PSP.	28 days

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Collaborators: Centre Hospitalier Universitaire de Saint Etienne; Centre Hospitalier Universitaire Dijon; CHU de Reims; Poitiers University Hospital; University Hospital, Clermont-Ferrand; Centre Hospitalier Universitaire de Nīmes; Centre Hospitalier de Roubaix; Groupe Hospitalier de la Region de Mulhouse et Sud Alsace; Centre Hospitalier de Bethune; Hopital Nord Franche-Comte; Centre Hospitalier de la Haute Saone; Centre Hospitalier Saint Philibert Lomme; Boulogne sur Mer Hospital Center; Centre Hospitalier Universitaire de Angers

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2013
• Primary Completion (Actual): June 30, 2014
• Study Completion (Actual): June 30, 2014

Study Registration Dates

• First Submitted: September 5, 2016
• First Submitted That Met QC Criteria: June 4, 2018
• First Posted (Actual): June 15, 2018

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 24, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: pressure; temperature; case-crossover; environment
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pneumothorax
• Other Study ID Numbers: API/2012/29

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No