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Completed

NCT Number: NCT03662230

Incidence and Severity of Acute Respiratory Distress Syndrome (ARDS) in the French Wounded Soldiers

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

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Key information

Conditions

Acute Respiratory Distress Syndrome Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital d'Instruction des Armées Sainte Anne

Toulon, Var, 83000, France

About this study

The Acute Respiratory Distress Syndrome (ARDS) complicates war wounds. Among the repatriated wounded persons, it can appear in the first 7 days.

It has been well described among American soldiers and it is known that it's serious, frequent and multifactorial.

However, not a single study has described the frequency and the severity of the ARDS in French wounded soldiers.

Thus the purpose of this study is to estimate the incidence and severity of the ARDS among the French wounded soldiers, admitted in continuing care and intensive care unit between 2001 and 2017.

The analysis of this data collection will let us improve the medical care of the ARDS in Outside Operation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • Opposition to the use of personal data

Treatment and study plan

Primary outcomes

  1. Incidence of ARDS

    Time frame: Day 7

    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.

Secondary outcomes

  1. Assess the severity of ARDS

    Time frame: 7 days

    the severity of ARDS will be assessed regarding the necessity or not of non-invasive and invasive ventilation

  2. Description of the severity of ARDS

    Time frame: 7 days

    the therapeutic intensity will be describe with : Maximal Positive end-expiration pressure (PEEP), curarisation, nitrogen monoxide (NO), prone position , Extracorporeal membrane oxygenation.

  3. Mortality

    Time frame: Day 90

    Assess the mortality since hospitalization

  4. Assessment of the severity of ARDS

    Time frame: 7 days

    the severity of ARDS will be assessed regarding duration of non-invasive and invasive ventilation

Sponsors and collaborators

Lead sponsor

Direction Centrale du Service de Santé des Armées

Other

Registry information

Acronym: SDRA-OPEX

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 7, 2018
Registry last updated
Mar 30, 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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