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Ventilation's Parameters Applied in Emergency Medicine. A Prospective Observational Study (PARAVENT)

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ClinicalTrials.gov Identifier: NCT03351920
Recruitment Status : Completed
First Posted : November 24, 2017
Last Update Posted : February 7, 2020
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital

Study Description
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Brief 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.

The study could be measure the proportion of patients developing an Acute Respiratory Failure Distress after a take care of by French Emergency Departments.


Condition or disease Intervention/treatment
Mechanical Ventilation Acute Respiratory Distress Syndrome Protective Ventilation Survival Other: mechanical ventilation

Study Design
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Study Type : Observational
Actual Enrollment : 229 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ventilation's Parameters Applied in Emergency Medicine. Observational Study
Actual Study Start Date : November 7, 2017
Actual Primary Completion Date : July 22, 2019
Actual Study Completion Date : August 8, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: mechanical ventilation
    All patients who need an invasive or non invasive mechanical ventilation, initiated in Prehospital or IntraHospital Emergency Department by an emergency Physician

Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Proportion of patients benefiting of an early protective ventilation in Emergency Departments [ Time Frame: Day 1 ]
  2. 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.

  3. Proportion of survival from day 1 to Day 8, and to day 28 [ Time Frame: from Day 1 to Day 8 and Day 28 ]
  4. Indication to mechanical ventilation in Prehospital care and Emergency Departments [ Time Frame: Day 1 ]
  5. Mechanical Ventilation Duration in Emergency Departments [ Time Frame: Day 1 ]
  6. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03351920


Locations
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France
Pierre-Arnaud Fort
Agen, France, 47600
CHU de Bordeaux
Bordeaux, France, 33000
Pierre-Marie Noël
Brest, France, 29200
Paul Fievet
La Rochelle, France, 17000
Thomas Lenormand
Lorient, France, 56322
CH de Niort
Niort, France, 79000
Marjanovic Nicolas
Poitiers, France, 86000
Sponsors and Collaborators
Poitiers University Hospital
More Information
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Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT03351920    
Other Study ID Numbers: PARAVENT
First Posted: November 24, 2017    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Emergencies
Disease Attributes
Pathologic Processes
 Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury