NCT03351920

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
229

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2017

Completed
14 days until next milestone

Study Start

First participant enrolled

November 7, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 24, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2019

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2019

Completed
Last Updated

February 7, 2020

Status Verified

February 1, 2020

Enrollment Period

1.7 years

First QC Date

October 24, 2017

Last Update Submit

February 6, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    Day 1

Secondary Outcomes (6)

  • Proportion of patients benefiting of an early protective ventilation in Emergency Departments

    Day 1

  • Proportion of patients with acute respiratory distress syndrome according to the Berlin Definition during the first eight days of following.

    from Day 1 to Day 8 and Day 28

  • Proportion of survival from day 1 to Day 8, and to day 28

    from Day 1 to Day 8 and Day 28

  • Indication to mechanical ventilation in Prehospital care and Emergency Departments

    Day 1

  • Mechanical Ventilation Duration in Emergency Departments

    Day 1

  • +1 more secondary outcomes

Interventions

All patients who need an invasive or non invasive mechanical ventilation, initiated in Prehospital or IntraHospital Emergency Department by an emergency Physician

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • \- Age under 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Pierre-Arnaud Fort

Agen, 47600, France

Location

CHU de Bordeaux

Bordeaux, 33000, France

Location

Pierre-Marie Noël

Brest, 29200, France

Location

Paul Fievet

La Rochelle, 17000, France

Location

Thomas Lenormand

Lorient, 56322, France

Location

CH de Niort

Niort, 79000, France

Location

Marjanovic Nicolas

Poitiers, 86000, France

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Respiration, Artificial

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsResuscitationEmergency TreatmentRespiratory Therapy

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2017

First Posted

November 24, 2017

Study Start

November 7, 2017

Primary Completion

July 22, 2019

Study Completion

August 8, 2019

Last Updated

February 7, 2020

Record last verified: 2020-02

Locations