Pre Hospital Evaluation of Video Laryngoscopy (EVE)

Pre Hospital Evaluation of Video Laryngoscopy : a Comparative Study of Macintosh and GLIDESCOPE Ranger®

The objective of this work is to compare standard intubation with video laryngoscope (Glide scope Ranger ) in French pre hospital multicentric study.

Study Overview

• Status: Withdrawn
• Conditions: Shock; Trauma, Nervous System; Cardiac Arrest; Respiratory Distress Syndrome; Drug Toxicity; Acute Post-trauma Stress State
• Intervention / Treatment: Device: Classical intubation; Device: GLIDESCOPE

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: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1: Classical intubation	Device: Classical intubation; Classical intubation
Experimental: 2: Glidescope intubation	Device: GLIDESCOPE; GLIDESCOPE intubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
IDS score in each group	during the intubation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Ministry of Health, France
• Investigators: Study Director: Patrick PLAISANCE, MD, PhD, Assistance Publique - Hôpitaux de Paris; Principal Investigator: Sébastien GALLULA, Ph, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: May 25, 2011
• First Submitted That Met QC Criteria: June 14, 2011
• First Posted (Estimate): June 15, 2011

Study Record Updates

• Last Update Posted (Estimate): May 8, 2014
• Last Update Submitted That Met QC Criteria: May 7, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Emergency intubation; Glide scope Ranger; Pre hospital
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Infant, Premature, Diseases; Wounds and Injuries; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Drug-Related Side Effects and Adverse Reactions; Trauma, Nervous System
• Other Study ID Numbers: P100205; 2010-A01512-37 (Other Identifier: IDRCB)