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

Acute Respiratory Distress Syndrome Clinical Trial

— SDRA-OPEX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03662230
• Other study ID #: SDRA-OPEX
• Status: Completed
• Start date: June 1, 2018
• Est. completion date: November 7, 2019

Study information

• Verified date: December 2019
• Source: Direction Centrale du Service de Santé des Armées
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 7, 2019
• Est. primary completion date: November 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Locations

Country	Name	City	State
France	Hôpital d'Instruction des Armées Sainte Anne	Toulon	Var

Sponsors (1)

Lead Sponsor	Collaborator
Direction Centrale du Service de Santé des Armées

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Mortality	Assess the mortality since hospitalization	Day 90
Secondary	Assessment of the severity of ARDS	the severity of ARDS will be assessed regarding duration of non-invasive and invasive ventilation	7 days