Pre Hospital Evaluation of Video Laryngoscopy

Phase 4

Withdrawn

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

• Registration Number: NCT01374061
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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 Timeline

• Study First Submitted: 2011-05-25
• Study Start: 2011-06
• Study First Submitted QC: 2011-06-14
• Study First Posted: 2011-06-15
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-07
• Last Update Posted: 2014-05-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1: Classical intubation	Classical intubation	-
2: Glidescope intubation	GLIDESCOPE	-

Primary Outcome Measures

Name	Time	Method
IDS score in each group	during the intubation

Secondary Outcome Measures

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