Spontaneous PneumothoraxEXPPONCT03557320
Environmental Factor and Onset of Spontaneous Pneumothorax
An observational study of Spontaneous Pneumothorax, run by Centre Hospitalier Universitaire de Besancon at 13 sites in France.
Trial summary
The study aims to evaluate the association between spontaneous pneumothorax onset and weather parameters. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spontaneous Pneumothorax
- How many people
- 3,090 participants
- Where
- 13 sitesFrance
- Study dates
- 31 May 2013to 30 Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- age over 18 years
- first episode of primary spontaneous pneumothorax
Who cannot join
- 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).
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
France13 sites
CHU Angers
Angers, 49100
Centre Hospitalier de Belfort
Belfort, 90016
CH Boulogne sur Mer
Boulogne-sur-Mer, 62320
CHU Clermont Ferrand
Clermont-Ferrand, 63003
CHU Dijon
Dijon, 21033
Polyclinique de DIVION
Divion, 62460
Clinique de HENIN BEAUMONT
Hénin-Beaumont, 62110
CH Lomme
Lomme, 59160
CH Mulhouse
Mulhouse, 68051
CHU Nimes
Nîmes, 30029
CHU Poitiers
Poitiers, 86000
CHU Toulouse
Toulouse, 31059
Centre Hospitalier de Vesoul
Vesoul, 70000
About this study
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
The study aims to evaluate the association between spontaneous pneumothorax onset and weather parameters.
Read the 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.
- Conditions
- Spontaneous Pneumothorax
- Keywords
- environment, pressure, temperature, case-crossover
- Medical subject headings
- Pneumothorax
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate odds ratio for the association between meteorological data and onset of PSP.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start31 May 2013
- Primary completion30 Jun 2014
- Study completion30 Jun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spontaneous PneumothoraxStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 3,090 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Collaborators
- 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, Boulogne sur Mer Hospital Center, Poitiers University Hospital, University Hospital, Clermont-Ferrand, University Hospital, Angers, Centre Hospitalier Universitaire de Nīmes
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03557320
- Sponsor's protocol ID
- API/2012/29
- Acronym
- EXPPO
- Status last verified
- Jan 2020
- First submitted
- 5 Sep 2016
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03557320
- Acronym / sponsor ID
- EXPPO / API/2012/29
- Conditions
- Spontaneous Pneumothorax
- Keywords
- environment, pressure, temperature, case-crossover
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,090 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- 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, Boulogne sur Mer Hospital Center, Poitiers University Hospital, University Hospital, Clermont-Ferrand, University Hospital, Angers, Centre Hospitalier Universitaire de Nīmes
- Study start
- 31 May 2013 (actual)
- Primary completion
- 30 Jun 2014 (actual)
- Study completion
- 30 Jun 2014 (actual)
- First posted
- 15 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- age over 18 years
- first episode of primary spontaneous pneumothorax
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Estimate odds ratio for the association between meteorological data and onset of PSP.
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spontaneous Pneumothorax, run by Centre Hospitalier Universitaire de Besancon at 13 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimate odds ratio for the association between meteorological data and onset of PSP. (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.