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

Primary Purpose

Cardiac Arrest, Coma, Major Trauma

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
MacIntosh Green Lite (metal single use laryngoscope blades)
MacIntosh Green Spec II (metal reusable laryngoscope blades)
Sponsored by
Henri Mondor University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring Intubation, Out-of-hospital, Laryngoscope, Blades, Emergency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Single use metallic blades

Classic reusable metallic blades

Outcomes

Primary Outcome Measures

Intubation success rate during at the first laryngoscopy

Secondary Outcome Measures

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

Full Information

First Posted
March 24, 2008
Last Updated
January 27, 2009
Sponsor
Henri Mondor University Hospital
Collaborators
SFMU
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1. Study Identification

Unique Protocol Identification Number
NCT00644722
Brief Title
Out-of-Hospital Intubation With Metal Single Use Laryngoscope Blades
Acronym
LAMETA
Official Title
Out-of-Hospital Intubation in Emergency Conditions With Either Metal Single Use or Reusable Laryngoscope Blades : Impact on Intubation Difficulties
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Henri Mondor University Hospital
Collaborators
SFMU

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest, Coma, Major Trauma, Respiratory Distress, Shock
Keywords
Intubation, Out-of-hospital, Laryngoscope, Blades, Emergency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Single use metallic blades
Arm Title
2
Arm Type
Active Comparator
Arm Description
Classic reusable metallic blades
Intervention Type
Device
Intervention Name(s)
MacIntosh Green Lite (metal single use laryngoscope blades)
Other Intervention Name(s)
Truphatek company -Israel, Smiths Medical France company
Intervention Description
metal single use laryngoscope blades
Intervention Type
Device
Intervention Name(s)
MacIntosh Green Spec II (metal reusable laryngoscope blades)
Other Intervention Name(s)
Truphatek company -Israel, Smiths Medical France company
Intervention Description
metal reusable laryngoscope blades
Primary Outcome Measure Information:
Title
Intubation success rate during at the first laryngoscopy
Time Frame
10 min
Secondary Outcome Measure Information:
Title
glottis exposure assessed by Cormack and Lehane classification
Time Frame
1 day
Title
difficult intubation rate assessed by the Intubation Difficult Score (IDS)
Time Frame
1 day
Title
the need for alternative airway techniques and the immediate post intubation complications rate
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
XAVIER COMBES, MD
Organizational Affiliation
Service d'anesthésie reanimation SAMU 94 - CHU H MONDOR
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service d'anesthésie reanimation SAMU 94 - CHU H MONDOR - APHP
City
Creteil
State/Province
Ile de France
ZIP/Postal Code
94010
Country
France

12. IPD Sharing Statement

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

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