NCT03662230

Brief Summary

The purpose of this study is to evaluate the incidence of the ARDS in the French wounded soldiers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

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

June 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 7, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2019

Completed
Last Updated

March 30, 2020

Status Verified

December 1, 2019

Enrollment Period

1.4 years

First QC Date

July 23, 2018

Last Update Submit

March 27, 2020

Conditions

Acute Respiratory Distress Syndrome

Keywords

war woundsintensive care unit

Outcome Measures

Primary Outcomes (1)

  • Incidence of ARDS

    The appearance of ARDS is defined by a ratio of partial pressure arterial oxygen (PaO2) and fraction of inspired oxygen (FiO2) lower than 300 in 7 days after the wound.

    Day 7

Secondary Outcomes (4)

  • Assess the severity of ARDS

    7 days

  • Description of the severity of ARDS

    7 days

  • Mortality

    Day 90

  • Assessment of the severity of ARDS

    7 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient evacuated from the theatre of outside operation and hospitalized in intensive care unit in France between 2001 et 2017

You may qualify if:

  • Patient evacuated from the theatre of outside operation and hospitalized in intensive care unit in France between 2001 et 2017

You may not qualify if:

  • Opposition to the use of personal data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital d'Instruction des Armées Sainte Anne

Toulon, Var, 83000, France

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Julien Bordes, professor

    Hopital d'Instruction des Armées Sainte Anne

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

July 23, 2018

First Posted

September 7, 2018

Study Start

June 1, 2018

Primary Completion

November 7, 2019

Study Completion

November 7, 2019

Last Updated

March 30, 2020

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)