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

Study Overview
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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.

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

Conditions
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Cardiac Arrest, Coma, Major Trauma, Respiratory Distress, Shock

Intervention / Treatment
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* Device: MacIntosh Green Lite (metal single use laryngoscope blades)
* Device: MacIntosh Green Spec II (metal reusable laryngoscope blades)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Single use metallic blades | Device: MacIntosh Green Lite (metal single use laryngoscope blades)<br>* metal single use laryngoscope blades<br>* Other names: Smiths Medical France company;|
| Active Comparator: 2<br>Classic reusable metallic blades | Device: MacIntosh Green Spec II (metal reusable laryngoscope blades)<br>* metal reusable laryngoscope blades<br>* Other names: Smiths Medical France company;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation success rate during at the first laryngoscopy |  | 10 min | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intubation, Out-of-hospital, Laryngoscope, Blades, Emergency