Out-of-Hospital Intubation With Metal Single Use Laryngoscope Blades

NCT ID: NCT00644722

Last Updated: 2009-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-01-31

Brief Summary

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New single use laryngoscope metal blades are available for intubation. This type of blade is safer than the reusable ones concerning the interhuman cross infection risk. No clinical studies have compared the two types of blades in the emergency context. The primary aim of this study is to demonstrate that single use blades are as efficient as the reusable ones concerning intubation conditions.

Detailed Description

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All adult patients requiring tracheal intubation in the pre hospital emergency context will be included. All intubation will be performed by an emergency physician or a nurse specialized in anesthesia. For patients with spontaneous cardiac activity, rapid sequence intubation will be performed to allow intubation.

Comparisons studied will be : Intubation success rate at the first laryngoscopy, glottis exposure assessed by Cormack and Lehane classification, difficult intubation rate assessed by the Intubation Difficult Score (IDS), the need for alternative airway techniques and the immediate post intubation complications rate as vomiting, dental trauma, pulmonary inhalation, arterial desaturation , hypotension episodes and cardiac arrest occurrence.

Conditions

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Cardiac Arrest Coma Major Trauma Respiratory Distress Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Single use metallic blades

Group Type ACTIVE_COMPARATOR

MacIntosh Green Lite (metal single use laryngoscope blades)

Intervention Type DEVICE

metal single use laryngoscope blades

2

Classic reusable metallic blades

Group Type ACTIVE_COMPARATOR

MacIntosh Green Spec II (metal reusable laryngoscope blades)

Intervention Type DEVICE

metal reusable laryngoscope blades

Interventions

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MacIntosh Green Lite (metal single use laryngoscope blades)

metal single use laryngoscope blades

Intervention Type DEVICE

MacIntosh Green Spec II (metal reusable laryngoscope blades)

metal reusable laryngoscope blades

Intervention Type DEVICE

Other Intervention Names

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Truphatek company -Israel Smiths Medical France company Truphatek company -Israel Smiths Medical France company

Eligibility Criteria

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Inclusion Criteria

* All adult patients requiring out-of-hospital intubation

Exclusion Criteria

* Patient under 18 years old
* Patients with criteria predictive of impossible intubation under direct laryngoscopy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SFMU

UNKNOWN

Sponsor Role collaborator

Henri Mondor University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Service d'anesthésie reanimation SAMU 94 - CHU H MONDOR

Principal Investigators

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XAVIER COMBES, MD

Role: PRINCIPAL_INVESTIGATOR

Service d'anesthésie reanimation SAMU 94 - CHU H MONDOR

Locations

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Service d'anesthésie reanimation SAMU 94 - CHU H MONDOR - APHP

Créteil, Île-de-France Region, France

Site Status

Countries

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France

Other Identifiers

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N° 2007-A00350-53

Identifier Type: -

Identifier Source: org_study_id

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