Acute Respiratory Distress SyndromeSDRA-OPEXNCT03662230
Incidence and Severity of Acute Respiratory Distress Syndrome (ARDS) in the French Wounded Soldiers
An observational study of Acute Respiratory Distress Syndrome, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
Trial summary
The purpose of this study is to evaluate the incidence of the ARDS in the French wounded soldiers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2018to 7 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient evacuated from the theatre of outside operation and hospitalized in intensive care unit in France between 2001 et 2017
Who may be able to join
- Patient evacuated from the theatre of outside operation and hospitalized in intensive care unit in France between 2001 et 2017
Who cannot join
- Opposition to the use of personal data
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the incidence of the ARDS in the French wounded soldiers.
Read the 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.
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- war wounds, intensive care unit
- Medical subject headings
- Respiratory Distress Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 7
Secondary outcomes (4)
Assess the severity of ARDS
the severity of ARDS will be assessed regarding the necessity or not of non-invasive and invasive ventilation
Measured: 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.
Measured: 7 days
Mortality
Assess the mortality since hospitalization
Measured: Day 90
Assessment of the severity of ARDS
the severity of ARDS will be assessed regarding duration of non-invasive and invasive ventilation
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start1 Jun 2018
- Primary completion7 Nov 2019
- Study completion7 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien Bordes, professor, Study director, Hopital d'Instruction des Armées Sainte Anne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03662230
- Sponsor's protocol ID
- SDRA-OPEX
- Acronym
- SDRA-OPEX
- Status last verified
- Dec 2019
- First submitted
- 23 Jul 2018
- Last updated
- 30 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Severity of Acute Respiratory Distress Syndrome (ARDS) in the French Wounded Soldiers
- ClinicalTrials.gov ID
- NCT03662230
- Acronym / sponsor ID
- SDRA-OPEX / SDRA-OPEX
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- war wounds, intensive care unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 7 Nov 2019 (actual)
- Study completion
- 7 Nov 2019 (actual)
- First posted
- 7 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient evacuated from the theatre of outside operation and hospitalized in intensive care unit in France between 2001 et 2017
Key inclusion criteria (1 listed)
- Patient evacuated from the theatre of outside operation and hospitalized in intensive care unit in France between 2001 et 2017
Key exclusion criteria (1 listed)
- Opposition to the use of personal data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Assess the severity of ARDS
Time frame: 7 days
Description of the severity of ARDS
Time frame: 7 days
Mortality
Time frame: Day 90
Assessment of the severity of ARDS
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julien Bordes, professor study director
Hopital d'Instruction des Armées Sainte Anne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of ARDS (time frame: Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2020; AzTrials last refreshed its copy on 8 Nov 2026.