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

  • France
      • Agen, France, 47600
        • Pierre-Arnaud Fort
      • Bordeaux, France, 33000
        • CHU de Bordeaux
      • Brest, France, 29200
        • Pierre-Marie Noël
      • La Rochelle, France, 17000
        • Paul Fievet
      • Lorient, France, 56322
        • Thomas Lenormand
      • Niort, France, 79000
        • CH de Niort
      • Poitiers, France, 86000
        • MARJANOVIC Nicolas

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

Poitiers University Hospital

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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