search
Back to results

Pre Hospital Evaluation of Video Laryngoscopy (EVE)

Primary Purpose

Cardiac Arrest, Respiratory Distress Syndrome, Shock

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Classical intubation
GLIDESCOPE
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring Emergency intubation, Glide scope Ranger, Pre hospital

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients of more than 18 years old
  • requiring an intubation
  • by medical out of hospital emergency operators
  • medical insurance
  • Consent signed

Exclusion Criteria:

  • Age <18, pregnant women
  • Refusal of consent or inability for understanding study
  • small mouth opening makes it impossible intubate

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    1: Classical intubation

    2: Glidescope intubation

    Arm Description

    Outcomes

    Primary Outcome Measures

    IDS score in each group

    Secondary Outcome Measures

    Vomit / regurgitation or inhalation per-procedure
    Dental or throat traumatism
    Broncho/laryngospasm
    Hypoxia
    Hemodynamic instability
    Inhalation pneumonia
    Failure of intubate

    Full Information

    First Posted
    May 25, 2011
    Last Updated
    May 7, 2014
    Sponsor
    Assistance Publique - Hôpitaux de Paris
    Collaborators
    Ministry of Health, France
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01374061
    Brief Title
    Pre Hospital Evaluation of Video Laryngoscopy
    Acronym
    EVE
    Official Title
    Pre Hospital Evaluation of Video Laryngoscopy : a Comparative Study of Macintosh and GLIDESCOPE Ranger®
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2014
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Sponsor decision
    Study Start Date
    June 2011 (undefined)
    Primary Completion Date
    December 2012 (Anticipated)
    Study Completion Date
    December 2012 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Assistance Publique - Hôpitaux de Paris
    Collaborators
    Ministry of Health, France

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The objective of this work is to compare standard intubation with video laryngoscope (Glide scope Ranger ) in French pre hospital multicentric study.
    Detailed Description
    Introduction: In France, patients in critical status brought to hospital by emergency physicians and nurses experimented in tracheal intubation. It is an invasive act allowing a protection of airways and an optimal oxygenation of the patients in distress. The reference technique is the direct laryngoscopy by Macintosh . Corresponding data shows that a video laryngoscope - GLIDESCOPE laryngoscope - improve the conditions of intubation in the surgical unit thanks to a better display(visualization) of the opening. A derived device for pre hospital emergency units (GLIDESCOPE Ranger®) deserves to be compared with the classic laryngoscopy in emergency conditions. Objectives: compare the emergency intubation in Pre hospital meadow by Glide Scope Ranger with regard to the classic method Progress of the study: the patients will be included by emergency physicians working in out of hospital teams of 3 major hospitals of Paris. The patients will be randomized in 2 groups: 1 group classic laryngoscopy (group 1) and a group Glide scope Ranger (group 2). The score IDS will be compared for every group as well as the arisen of a complication during the procedure. The consent will be collected on the place or during the hospitalization.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiac Arrest, Respiratory Distress Syndrome, Shock, Acute Post-trauma Stress State, Drug Toxicity, Trauma, Nervous System
    Keywords
    Emergency intubation, Glide scope Ranger, Pre hospital

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1: Classical intubation
    Arm Type
    Active Comparator
    Arm Title
    2: Glidescope intubation
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    Classical intubation
    Intervention Description
    Classical intubation
    Intervention Type
    Device
    Intervention Name(s)
    GLIDESCOPE
    Intervention Description
    GLIDESCOPE intubation
    Primary Outcome Measure Information:
    Title
    IDS score in each group
    Time Frame
    during the intubation
    Secondary Outcome Measure Information:
    Title
    Vomit / regurgitation or inhalation per-procedure
    Time Frame
    during the intubation
    Title
    Dental or throat traumatism
    Time Frame
    during the intubation
    Title
    Broncho/laryngospasm
    Time Frame
    during the intubation
    Title
    Hypoxia
    Time Frame
    per intubation
    Title
    Hemodynamic instability
    Time Frame
    per intubation
    Title
    Inhalation pneumonia
    Time Frame
    within 24 hours following the inclusion
    Title
    Failure of intubate
    Time Frame
    during the intubation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients of more than 18 years old requiring an intubation by medical out of hospital emergency operators medical insurance Consent signed Exclusion Criteria: Age <18, pregnant women Refusal of consent or inability for understanding study small mouth opening makes it impossible intubate
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sébastien GALLULA, Ph
    Organizational Affiliation
    Assistance Publique - Hôpitaux de Paris
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Patrick PLAISANCE, MD, PhD
    Organizational Affiliation
    Assistance Publique - Hôpitaux de Paris
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Pre Hospital Evaluation of Video Laryngoscopy

    We'll reach out to this number within 24 hrs