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Completed

NCT Number: NCT03557320

Environmental Factor and Onset of Spontaneous Pneumothorax

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Angers, Angers, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Estimate odds ratio for the association between meteorological data and onset of PSP.

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Collaborators

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

Registry information

Official study 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

Acronym: EXPPO

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 15, 2018
Registry last updated
Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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