NCT03557320

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,090

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2013

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 31, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2014

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 5, 2016

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

June 15, 2018

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

1.1 years

First QC Date

September 5, 2016

Last Update Submit

January 24, 2020

Conditions

Spontaneous Pneumothorax

Keywords

environmentpressuretemperaturecase-crossover

Outcome Measures

Primary Outcomes (1)

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

    28 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • age over 18 years
  • first episode of primary spontaneous pneumothorax

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

CHU Angers

Angers, 49100, France

Location

Centre Hospitalier de Belfort

Belfort, 90016, France

Location

CH Boulogne sur Mer

Boulogne-sur-Mer, 62320, France

Location

CHU Clermont Ferrand

Clermont-Ferrand, 63003, France

Location

CHU Dijon

Dijon, 21033, France

Location

Polyclinique de DIVION

Divion, 62460, France

Location

Clinique de HENIN BEAUMONT

Hénin-Beaumont, 62110, France

Location

CH Lomme

Lomme, 59160, France

Location

CH Mulhouse

Mulhouse, 68051, France

Location

CHU Nimes

Nîmes, 30029, France

Location

CHU Poitiers

Poitiers, 86000, France

Location

CHU Toulouse

Toulouse, 31059, France

Location

Centre Hospitalier de Vesoul

Vesoul, 70000, France

Location

MeSH Terms

Conditions

Pneumothorax

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2016

First Posted

June 15, 2018

Study Start

May 31, 2013

Primary Completion

June 30, 2014

Study Completion

June 30, 2014

Last Updated

January 27, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(13)