Pre Hospital Evaluation of Video Laryngoscopy

NCT ID: NCT01374061

Last Updated: 2014-05-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2012-12-31

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.

Conditions

Cardiac Arrest; Respiratory Distress Syndrome; Shock; Acute Post-trauma Stress State; Drug Toxicity; Trauma, Nervous System

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1: Classical intubation

Group Type: ACTIVE_COMPARATOR

Classical intubation

Intervention Type: DEVICE

Classical intubation

2: Glidescope intubation

Group Type: EXPERIMENTAL

GLIDESCOPE

Intervention Type: DEVICE

GLIDESCOPE intubation

Interventions

Classical intubation

Classical intubation

Intervention Type: DEVICE

GLIDESCOPE

GLIDESCOPE intubation

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sébastien GALLULA, Ph

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Patrick PLAISANCE, MD, PhD

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Paris

Other Identifiers

2010-A01512-37

Identifier Type: OTHER

Identifier Source: secondary_id

P100205

Identifier Type: -

Identifier Source: org_study_id