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EXPPO: Environmental Factor and Onset of Spontaneous Pneumothorax

Sponsor
Centre Hospitalier Universitaire de Besancon (Other)
Overall Status
Completed
CT.gov ID
NCT03557320
Collaborator
Centre Hospitalier Universitaire de Saint Etienne (Other), Centre Hospitalier Universitaire Dijon (Other), Hopital Nord Franche-Comte (Other), Groupe Hospitalier de la Region de Mulhouse et Sud Alsace (Other), Centre Hospitalier de la Haute Saone (Other), CHU de Reims (Other), Centre Hospitalier de Bethune (Other), Centre Hospitalier Saint Philibert Lomme (Other), Centre Hospitalier de Roubaix (Other), Centre Hospitalier de Boulogne sur Mer (Other), Poitiers University Hospital (Other), University Hospital, Clermont-Ferrand (Other), Centre Hospitalier Universitaire de Angers (Other), Centre Hospitalier Universitaire de Nīmes (Other)
3,090
Enrollment
13
Locations
13
Actual Duration (Months)
237.7
Patients Per Site
18.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    3090 participants
    Observational Model:
    Case-Crossover
    Time Perspective:
    Retrospective
    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
    Actual Study Start Date :
    May 31, 2013
    Actual Primary Completion Date :
    Jun 30, 2014
    Actual Study Completion Date :
    Jun 30, 2014

    Outcome Measures

    Primary Outcome Measures

    1. Estimate odds ratio for the association between meteorological data and onset of PSP. [28 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU Angers Angers France 49100
    2 Centre Hospitalier de Belfort Belfort France 90016
    3 CH Boulogne sur Mer Boulogne sur Mer France 62320
    4 CHU Clermont Ferrand Clermont Ferrand France 63003
    5 CHU Dijon Dijon France 21033
    6 Polyclinique de DIVION Divion France 62460
    7 Clinique de HENIN BEAUMONT Henin Beaumont France 62110
    8 CH Lomme Lomme France 59160
    9 CH Mulhouse Mulhouse France 68051
    10 CHU Nimes Nimes France 30029
    11 CHU Poitiers Poitiers France 86000
    12 CHU Toulouse Toulouse France 31059
    13 Centre Hospitalier de Vesoul Vesoul France 70000

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire de Besancon
    ClinicalTrials.gov Identifier:
    NCT03557320
    Other Study ID Numbers:
    • API/2012/29
    First Posted:
    Jun 15, 2018
    Last Update Posted:
    Jan 27, 2020
    Last Verified:
    Jan 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Centre Hospitalier Universitaire de Besancon
    environment
    pressure
    temperature
    case-crossover
    Additional relevant MeSH terms:
    Pneumothorax

    Study Results

    No Results Posted as of Jan 27, 2020