Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date July 23, 2018
First Posted Date September 7, 2018
Last Update Posted Date March 30, 2020
Actual Study Start Date June 1, 2018
Actual Primary Completion Date November 7, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 5, 2018)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 5, 2018)
  • 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
  • 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.
  • Mortality [ Time Frame: Day 90 ]
    Assess the mortality since hospitalization
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Incidence and Severity of Acute Respiratory Distress Syndrome (ARDS) in the French Wounded Soldiers
Official Title Incidence and Severity of Acute Respiratory Distress Syndrome (ARDS) in the French Wounded Soldiers
Brief Summary The purpose of this study is to evaluate the incidence of the ARDS in the French wounded soldiers.
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
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Acute Respiratory Distress Syndrome
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 5, 2018)
100
Original Estimated Enrollment Same as current
Actual Study Completion Date November 7, 2019
Actual Primary Completion Date November 7, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03662230
Other Study ID Numbers SDRA-OPEX
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Direction Centrale du Service de Santé des Armées
Study Sponsor Direction Centrale du Service de Santé des Armées
Collaborators Not Provided
Investigators
Study Director: Julien Bordes, professor Hopital d'Instruction des Armées Sainte Anne
PRS Account Direction Centrale du Service de Santé des Armées
Verification Date December 2019