Mechanical VentilationPARAVENTNCT03351920
Ventilation's Parameters Applied in Emergency Medicine. A Prospective Observational Study
An observational study of Mechanical Ventilation and Acute Respiratory Distress Syndrome, run by Poitiers University Hospital at 7 sites in France.
Trial summary
To prospectively assess the mechanical ventilation management when its provided by Emergency Physicians in French Hospital, and to assess complications and outcome of these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation, Acute Respiratory Distress Syndrome, Protective Ventilation
- What is being tested?
- mechanical ventilation
- How many people
- 229 participants
- Where
- 7 sitesFrance
- Study dates
- 7 Nov 2017to 8 Aug 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: All patients who need an invasive or non invasive mechanical ventilation, initiated in Prehospital or IntraHospital Emergency Department by an emergency Physician
Who may be able to join
- Age equal or over 18 years old
- Needing a invasive or noninvasive mechanical ventilation
- Mechanical ventilation initiated in Prehospital or IntraHospital Emergency Department by an Emergency Physician
Who cannot join
- Age under 18 years old
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Pierre-Arnaud Fort
Agen, 47600
CHU de Bordeaux
Bordeaux, 33000
Pierre-Marie Noël
Brest, 29200
Paul Fievet
La Rochelle, 17000
Thomas Lenormand
Lorient, 56322
CH de Niort
Niort, 79000
Marjanovic Nicolas
Poitiers, 86000
About this study
Official title: Ventilation's Parameters Applied in Emergency Medicine. Observational Study
To prospectively assess the mechanical ventilation management when its provided by Emergency Physicians in French Hospital, and to assess complications and outcome of these patients.
The study could be measure the proportion of patients developing an Acute Respiratory Failure Distress after a take care of by French Emergency Departments.
- Conditions
- Mechanical Ventilation, Acute Respiratory Distress Syndrome, Protective Ventilation, Survival
- Being tested
- mechanical ventilation
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical ventilationOther
All patients who need an invasive or non invasive mechanical ventilation, initiated in Prehospital or IntraHospital Emergency Department by an emergency Physician
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients benefiting of a early low-volume ventilation initiated Emergency Department or Prehospital Care.
Early Low volume ventilation will be defined according to a VtE < 8mL/lg
Measured: Day 1
Secondary outcomes (6)
Proportion of patients benefiting of an early protective ventilation in Emergency Departments
Measured: Day 1
Proportion of patients with acute respiratory distress syndrome according to the Berlin Definition during the first eight days of following.
ARDS will be defined according to the Berlin definition.
Measured: from Day 1 to Day 8 and Day 28
Proportion of survival from day 1 to Day 8, and to day 28
Measured: from Day 1 to Day 8 and Day 28
Indication to mechanical ventilation in Prehospital care and Emergency Departments
Measured: Day 1
Mechanical Ventilation Duration in Emergency Departments
Measured: Day 1
Mechanical ventilation settings in Emergency Departments
Recorded settings will be Ventilation mode, Tidal volume or Pressure Support Positive End Expiratory Pressure, Ventilation Rate, I : E ratio or Inspiratory Flow or Inspiratory Time.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start7 Nov 2017
- Primary completion22 Jul 2019
- Study completion8 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03351920
- Sponsor's protocol ID
- PARAVENT
- Acronym
- PARAVENT
- Status last verified
- Feb 2020
- First submitted
- 24 Oct 2017
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventilation's Parameters Applied in Emergency Medicine. Observational Study
- ClinicalTrials.gov ID
- NCT03351920
- Acronym / sponsor ID
- PARAVENT / PARAVENT
- Conditions
- Mechanical Ventilation, Acute Respiratory Distress Syndrome, Protective Ventilation, Survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 7 Nov 2017 (actual)
- Primary completion
- 22 Jul 2019 (actual)
- Study completion
- 8 Aug 2019 (actual)
- First posted
- 24 Nov 2017 (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.
To prospectively assess the mechanical ventilation management when its provided by Emergency Physicians in French Hospital, and to assess complications and outcome of these patients.
The study could be measure the proportion of patients developing an Acute Respiratory Failure Distress after a take care of by French Emergency Departments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who need an invasive or non invasive mechanical ventilation, initiated in Prehospital or IntraHospital Emergency Department by an emergency Physician
Key inclusion criteria (3 listed)
- Age equal or over 18 years old
- Needing a invasive or noninvasive mechanical ventilation
- Mechanical ventilation initiated in Prehospital or IntraHospital Emergency Department by an Emergency Physician
Key exclusion criteria (1 listed)
- Age under 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mechanical ventilationAll patients who need an invasive or non invasive mechanical ventilation, initiated in Prehospital or IntraHospital Emergency Department by an emergency Physician | Other | – |
Primary outcome
Proportion of patients benefiting of a early low-volume ventilation initiated Emergency Department or Prehospital Care.
Time frame: Day 1
Early Low volume ventilation will be defined according to a VtE < 8mL/lg
6 secondary outcomes
Proportion of patients benefiting of an early protective ventilation in Emergency Departments
Time frame: Day 1
Proportion of patients with acute respiratory distress syndrome according to the Berlin Definition during the first eight days of following.
Time frame: from Day 1 to Day 8 and Day 28
Proportion of survival from day 1 to Day 8, and to day 28
Time frame: from Day 1 to Day 8 and Day 28
Indication to mechanical ventilation in Prehospital care and Emergency Departments
Time frame: Day 1
Mechanical Ventilation Duration in Emergency Departments
Time frame: Day 1
Mechanical ventilation settings in Emergency Departments
Time frame: Day 1
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 7 Feb 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation and Acute Respiratory Distress Syndrome, run by Poitiers University Hospital at 7 sites 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 3 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 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Proportion of patients benefiting of a early low-volume ventilation initiated Emergency Department or Prehospital Care. (time frame: Day 1). 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 7 Feb 2020.