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

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

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• France
  • Var
    • Toulon, Var, France, 83000
      • Hôpital d'Instruction des Armées Sainte Anne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the severity of ARDS	the severity of ARDS will be assessed regarding the necessity or not of non-invasive and invasive ventilation	7 days
Description of the severity of ARDS	the therapeutic intensity will be describe with : Maximal Positive end-expiration pressure (PEEP), curarisation, nitrogen monoxide (NO), prone position , Extracorporeal membrane oxygenation.	7 days
Mortality	Assess the mortality since hospitalization	Day 90
Assessment of the severity of ARDS	the severity of ARDS will be assessed regarding duration of non-invasive and invasive ventilation	7 days

Collaborators and Investigators

• Sponsor: Direction Centrale du Service de Santé des Armées
• Investigators: Study Director: Julien Bordes, professor, Hôpital d'Instruction des Armées Sainte Anne

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): November 7, 2019
• Study Completion (Actual): November 7, 2019

Study Registration Dates

• First Submitted: July 23, 2018
• First Submitted That Met QC Criteria: September 5, 2018
• First Posted (Actual): September 7, 2018

Study Record Updates

• Last Update Posted (Actual): March 30, 2020
• Last Update Submitted That Met QC Criteria: March 27, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: intensive care unit; war wounds
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: SDRA-OPEX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No