Pre Hospital Evaluation of Video Laryngoscopy

Cardiac Arrest Clinical Trial

— EVE  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01374061
• Other study ID #: P100205
• Secondary ID: 2010-A01512-37
• Status: Withdrawn
• Phase: Phase 4
• First received: May 25, 2011
• Last updated: May 7, 2014
• Start date: June 2011
• Est. completion date: December 2012

Study information

• Verified date: May 2014
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Post-trauma Stress State
• Cardiac Arrest
• Drug Toxicity
• Heart Arrest
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Shock
• Stress Disorders, Post-Traumatic
• Trauma, Nervous System

Intervention

Device:
• Classical intubation
Classical intubation
• GLIDESCOPE
GLIDESCOPE intubation

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Ministry of Health, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IDS score in each group		during the intubation	Yes
Secondary	Vomit / regurgitation or inhalation per-procedure		during the intubation	Yes
Secondary	Dental or throat traumatism		during the intubation	Yes
Secondary	Broncho/laryngospasm		during the intubation	Yes
Secondary	Hypoxia		per intubation	Yes
Secondary	Hemodynamic instability		per intubation	Yes
Secondary	Inhalation pneumonia		within 24 hours following the inclusion	Yes
Secondary	Failure of intubate		during the intubation	Yes