Out-of-Hospital Intubation With Metal Single Use Laryngoscope Blades (LAMETA)

January 27, 2009 updated by: Henri Mondor University Hospital

Out-of-Hospital Intubation in Emergency Conditions With Either Metal Single Use or Reusable Laryngoscope Blades : Impact on Intubation Difficulties

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.

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

800

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ile de France
      • Creteil, Ile de France, France, 94010
        • Service d'anesthésie reanimation SAMU 94 - CHU H MONDOR - APHP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Single use metallic blades
metal single use laryngoscope blades
Other Names:
  • Truphatek company -Israel
  • Smiths Medical France company
Active Comparator: 2
Classic reusable metallic blades
metal reusable laryngoscope blades
Other Names:
  • Truphatek company -Israel
  • Smiths Medical France company

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intubation success rate during at the first laryngoscopy
Time Frame: 10 min
10 min

Secondary Outcome Measures

Outcome Measure
Time Frame
glottis exposure assessed by Cormack and Lehane classification
Time Frame: 1 day
1 day
difficult intubation rate assessed by the Intubation Difficult Score (IDS)
Time Frame: 1 day
1 day
the need for alternative airway techniques and the immediate post intubation complications rate
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: XAVIER COMBES, MD, Service d'anesthésie reanimation SAMU 94 - CHU H MONDOR

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

March 24, 2008

First Submitted That Met QC Criteria

March 24, 2008

First Posted (Estimate)

March 27, 2008

Study Record Updates

Last Update Posted (Estimate)

January 29, 2009

Last Update Submitted That Met QC Criteria

January 27, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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