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

Acute Respiratory Distress Syndrome Clinical Trial

— PARAVENT  

Official title:

Ventilation's Parameters Applied in Emergency Medicine. Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03351920
• Other study ID #: PARAVENT
• Status: Completed
• Start date: November 7, 2017
• Est. completion date: August 8, 2019

Study information

• Verified date: February 2020
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 229
• Est. completion date: August 8, 2019
• Est. primary completion date: July 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Emergencies
• Mechanical Ventilation
• Protective Ventilation
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Survival

Intervention

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

Locations

Country	Name	City	State
France	Pierre-Arnaud Fort	Agen
France	CHU de Bordeaux	Bordeaux
France	Pierre-Marie Noël	Brest
France	Paul Fievet	La Rochelle
France	Thomas Lenormand	Lorient
France	CH de Niort	Niort
France	Marjanovic Nicolas	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of patients benefiting of an early protective ventilation in Emergency Departments		Day 1
Secondary	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.	from Day 1 to Day 8 and Day 28
Secondary	Proportion of survival from day 1 to Day 8, and to day 28		from Day 1 to Day 8 and Day 28
Secondary	Indication to mechanical ventilation in Prehospital care and Emergency Departments		Day 1
Secondary	Mechanical Ventilation Duration in Emergency Departments		Day 1
Secondary	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.	Day 1