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

Sponsor:

Collaborator:

Ministry of Health, France

Information provided by (Responsible Party):

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT01374061

First received: May 25, 2011

Last updated: October 28, 2011

Last verified: May 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

May 25, 2011

Last Updated Date

October 28, 2011

Start Date ^ICMJE

June 2011

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

IDS score in each group [ Time Frame: during the intubation ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01374061 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Arm (s)

Active Comparator: 1: Classical intubation
NA

Intervention: Device: Classical intubation
Experimental: 2: Glidescope intubation
NA

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

Recruiting

Estimated Enrollment ^ICMJE

262

Estimated Completion Date

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Sébastien GALLULA, Ph	33 1 49 95 61 61	sebastien.gallula@lrb.aphp.fr
Contact: Patrick PLAISANCE, MD-PHD	33 1 49 95 61 93	patrick.plaisance@lrb.aphp.fr

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01374061

Other Study ID Numbers ^ICMJE

P100205, 2010-A01512-37

Has Data Monitoring Committee

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

Information Provided By

Assistance Publique - Hôpitaux de Paris

Verification Date

May 2011

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

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