- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03351920
Ventilation's Parameters Applied in Emergency Medicine. A Prospective Observational Study (PARAVENT)
February 6, 2020 updated by: Poitiers University Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
229
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Agen, France, 47600
- Pierre-Arnaud Fort
-
Bordeaux, France, 33000
- CHU de Bordeaux
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Brest, France, 29200
- Pierre-Marie Noël
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La Rochelle, France, 17000
- Paul Fievet
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Lorient, France, 56322
- Thomas Lenormand
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Niort, France, 79000
- CH de Niort
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Poitiers, France, 86000
- MARJANOVIC Nicolas
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
All patients who need an invasive or non invasive mechanical ventilation, initiated in Prehospital or IntraHospital Emergency Department by an emergency Physician
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Age under 18 years old
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of patients benefiting of an early protective ventilation in Emergency Departments
Time Frame: Day 1
|
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
|
ARDS will be defined according to the Berlin definition.
|
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
|
from Day 1 to Day 8 and Day 28
|
|
Indication to mechanical ventilation in Prehospital care and Emergency Departments
Time Frame: Day 1
|
Day 1
|
|
Mechanical Ventilation Duration in Emergency Departments
Time Frame: Day 1
|
Day 1
|
|
Mechanical ventilation settings in Emergency Departments
Time Frame: Day 1
|
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.
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 7, 2017
Primary Completion (Actual)
July 22, 2019
Study Completion (Actual)
August 8, 2019
Study Registration Dates
First Submitted
October 24, 2017
First Submitted That Met QC Criteria
November 21, 2017
First Posted (Actual)
November 24, 2017
Study Record Updates
Last Update Posted (Actual)
February 7, 2020
Last Update Submitted That Met QC Criteria
February 6, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PARAVENT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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