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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03662230
Recruitment Status : Completed
First Posted : September 7, 2018
Last Update Posted : March 30, 2020
Sponsor:
Information provided by (Responsible Party):
Direction Centrale du Service de Santé des Armées

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

Condition or disease
Acute Respiratory Distress Syndrome

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Incidence and Severity of Acute Respiratory Distress Syndrome (ARDS) in the French Wounded Soldiers
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : November 7, 2019
Actual Study Completion Date : November 7, 2019





Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient evacuated from the theatre of outside operation and hospitalized in intensive care unit in France between 2001 et 2017
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03662230


Locations
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France
Hôpital d'Instruction des Armées Sainte Anne
Toulon, Var, France, 83000
Sponsors and Collaborators
Direction Centrale du Service de Santé des Armées
Investigators
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Study Director: Julien Bordes, professor Hopital d'Instruction des Armées Sainte Anne
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Responsible Party: Direction Centrale du Service de Santé des Armées
ClinicalTrials.gov Identifier: NCT03662230    
Other Study ID Numbers: SDRA-OPEX
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Direction Centrale du Service de Santé des Armées:
war wounds
intensive care unit
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury