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Pre Hospital Evaluation of Video Laryngoscopy (EVE)

This study has been withdrawn prior to enrollment.
(Sponsor decision)
Ministry of Health, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris Identifier:
First received: May 25, 2011
Last updated: May 7, 2014
Last verified: May 2014
The objective of this work is to compare standard intubation with video laryngoscope (Glide scope Ranger ) in French pre hospital multicentric study.

Condition Intervention Phase
Cardiac Arrest
Respiratory Distress Syndrome
Acute Post-trauma Stress State
Drug Toxicity
Trauma, Nervous System
Device: Classical intubation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pre Hospital Evaluation of Video Laryngoscopy : a Comparative Study of Macintosh and GLIDESCOPE Ranger®

Resource links provided by NLM:

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • IDS score in each group [ Time Frame: during the intubation ]

Secondary Outcome Measures:
  • Vomit / regurgitation or inhalation per-procedure [ Time Frame: during the intubation ]
  • Dental or throat traumatism [ Time Frame: during the intubation ]
  • Broncho/laryngospasm [ Time Frame: during the intubation ]
  • Hypoxia [ Time Frame: per intubation ]
  • Hemodynamic instability [ Time Frame: per intubation ]
  • Inhalation pneumonia [ Time Frame: within 24 hours following the inclusion ]
  • Failure of intubate [ Time Frame: during the intubation ]

Enrollment: 0
Study Start Date: June 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1: Classical intubation Device: Classical intubation
Classical intubation
Experimental: 2: Glidescope intubation Device: GLIDESCOPE
GLIDESCOPE intubation

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.


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

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01374061

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France
Principal Investigator: Sébastien GALLULA, Ph Assistance Publique - Hôpitaux de Paris
Study Director: Patrick PLAISANCE, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT01374061     History of Changes
Other Study ID Numbers: P100205
2010-A01512-37 ( Other Identifier: IDRCB )
Study First Received: May 25, 2011
Last Updated: May 7, 2014

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Emergency intubation
Glide scope Ranger
Pre hospital

Additional relevant MeSH terms:
Heart Arrest
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Drug-Related Side Effects and Adverse Reactions
Trauma, Nervous System
Stress Disorders, Post-Traumatic
Heart Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Chemically-Induced Disorders
Nervous System Diseases
Wounds and Injuries
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders processed this record on April 21, 2017