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Pre Hospital Evaluation of Video Laryngoscopy (EVE)

This study has been withdrawn prior to enrollment.
(Sponsor decision)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01374061
First Posted: June 15, 2011
Last Update Posted: May 8, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  Purpose
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 Shock Acute Post-trauma Stress State Drug Toxicity Trauma, Nervous System Device: Classical intubation Device: GLIDESCOPE Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01374061


Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France
Investigators
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
ClinicalTrials.gov Identifier: NCT01374061     History of Changes
Other Study ID Numbers: P100205
2010-A01512-37 ( Other Identifier: IDRCB )
First Submitted: May 25, 2011
First Posted: June 15, 2011
Last Update Posted: May 8, 2014
Last Verified: May 2014

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

Additional relevant MeSH terms:
Wounds and Injuries
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
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders