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Pre Hospital Evaluation of Video Laryngoscopy (EVE)

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.
 
ClinicalTrials.gov Identifier: NCT01374061
Recruitment Status : Withdrawn (Sponsor decision)
First Posted : June 15, 2011
Last Update Posted : May 8, 2014
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE May 25, 2011
First Posted Date  ICMJE June 15, 2011
Last Update Posted Date May 8, 2014
Study Start Date  ICMJE June 2011
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2011)
IDS score in each group [ Time Frame: during the intubation ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2011)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pre Hospital Evaluation of Video Laryngoscopy
Official Title  ICMJE Pre Hospital Evaluation of Video Laryngoscopy : a Comparative Study of Macintosh and GLIDESCOPE Ranger®
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cardiac Arrest
  • Respiratory Distress Syndrome
  • Shock
  • Acute Post-trauma Stress State
  • Drug Toxicity
  • Trauma, Nervous System
Intervention  ICMJE
  • Device: Classical intubation
    Classical intubation
  • Device: GLIDESCOPE
    GLIDESCOPE intubation
Study Arms  ICMJE
  • Active Comparator: 1: Classical intubation
    Intervention: Device: Classical intubation
  • Experimental: 2: Glidescope intubation
    Intervention: Device: GLIDESCOPE
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 7, 2014)
0
Original Estimated Enrollment  ICMJE
 (submitted: June 14, 2011)
262
Estimated Study Completion Date  ICMJE December 2012
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries France
 
Administrative Information
NCT Number  ICMJE NCT01374061
Other Study ID Numbers  ICMJE P100205
2010-A01512-37 ( Other Identifier: IDRCB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Ministry of Health, France
Investigators  ICMJE
Principal Investigator: Sébastien GALLULA, Ph Assistance Publique - Hôpitaux de Paris
Study Director: Patrick PLAISANCE, MD, PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP