EVE: Pre Hospital Evaluation of Video Laryngoscopy

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01374061

Collaborator

Ministry of Health, France (Other)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cardiac Arrest Respiratory Distress Syndrome Shock Acute Post-trauma Stress State Drug Toxicity Trauma, Nervous System	Device: Classical intubation Device: GLIDESCOPE	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

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®

Study Start Date :

Jun 1, 2011

Anticipated Primary Completion Date :

Dec 1, 2012

Anticipated Study Completion Date :

Dec 1, 2012

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: 1: Classical intubation

Device: Classical intubation

Classical intubation

Experimental: 2: Glidescope intubation

Device: GLIDESCOPE

GLIDESCOPE intubation

Outcome Measures

Primary Outcome Measures

IDS score in each group [during the intubation]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

No locations specified.

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