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

• Sponsor: Poitiers University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03351920
• Collaborator: (none)
• Enrollment: 229
• Locations: 7
• Actual Duration (Months): 21
• Patients Per Site: 32.7
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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	Phase
Mechanical Ventilation; Acute Respiratory Distress Syndrome; Protective Ventilation; Survival	Other: mechanical ventilation

Study Design

• 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: Nov 7, 2017
• Actual Primary Completion Date: Jul 22, 2019
• Actual Study Completion Date: Aug 8, 2019

Outcome Measures

Primary Outcome Measures

1. Proportion of patients benefiting of a early low-volume ventilation initiated Emergency Department or Prehospital Care. [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 [Day 1]

2. 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]

   ARDS will be defined according to the Berlin definition.

3. Proportion of survival from day 1 to Day 8, and to day 28 [from Day 1 to Day 8 and Day 28]

4. Indication to mechanical ventilation in Prehospital care and Emergency Departments [Day 1]

5. Mechanical Ventilation Duration in Emergency Departments [Day 1]

6. Mechanical ventilation settings in Emergency Departments [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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Pierre-Arnaud Fort	Agen		France	47600
2	CHU de Bordeaux	Bordeaux		France	33000
3	Pierre-Marie Noël	Brest		France	29200
4	Paul Fievet	La Rochelle		France	17000
5	Thomas Lenormand	Lorient		France	56322
6	CH de Niort	Niort		France	79000
7	Marjanovic Nicolas	Poitiers		France	86000

Sponsors and Collaborators

• Poitiers University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Poitiers University Hospital
• ClinicalTrials.gov Identifier: NCT03351920
• Other Study ID Numbers: PARAVENT
• First Posted: Nov 24, 2017
• Last Update Posted: Feb 7, 2020
• Last Verified: Feb 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Emergencies

Study Results

No Results Posted as of Feb 7, 2020