Pre Hospital Evaluation of Video Laryngoscopy (EVE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was  Recruiting
Ministry of Health, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris Identifier:
First received: May 25, 2011
Last updated: October 28, 2011
Last verified: May 2011

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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: Yes ]

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

Estimated Enrollment: 262
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
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
Genders Eligible for Study:   Both
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
Please refer to this study by its identifier: NCT01374061

Contact: Sébastien GALLULA, Ph 33 1 49 95 61 61
Contact: Patrick PLAISANCE, MD-PHD 33 1 49 95 61 93

SAU-SMUR - Lariboisière Recruiting
Paris, France, 75010
Principal Investigator: Sébastien GALLULA, MD, PhD         
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

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT01374061     History of Changes
Other Study ID Numbers: P100205, 2010-A01512-37
Study First Received: May 25, 2011
Last Updated: October 28, 2011
Health Authority: France: Ministry of Health

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

Additional relevant MeSH terms:
Drug Toxicity
Heart Arrest
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Wounds and Injuries
Stress Disorders, Post-Traumatic
Trauma, Nervous System
Substance-Related Disorders
Heart Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Pathologic Processes
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Nervous System Diseases processed this record on April 17, 2014