Videolaryngoscopy Compared to Direct Laryngoscopy

Study Overview
=================
Brief Summary
-----------------
Videolaryngoscope (Macintosh-type blade) compared with direct laryngoscopy for rapid sequence intubation in the operating room

Detailed Description
-----------------
Video laryngoscopy (VL) is a etablished method of achieving tracheal intubation and there is evidence to show that visualisation of larynx can be improved using VL in failed tracheal Intubation (NAP 4 Report). VL has been shown to improve first attempt success compared to direct laryngoscopy in many clinical settings including intensive care unit (ICU) and emergency department (ED). This is a proposed comparison study of a VL, use in patients with a high risk for pulmonary Aspiration and requiring tracheal Intubation. An national, multi-center, prospective randomized comparative trial is proposed testing the superiority of oral tracheal intubation with the McGrath® MAC versus conventional laryngoscope in adult patients under general anesthesia.

Official Title
-----------------
Evaluation of Videolaryngoscopy (McGrath Mac) Compared to Direct Laryngoscopy for Rapid Sequence Intubation in Operating Room

Conditions
-----------------
Pulmonary Aspiration of Gastric Contents

Intervention / Treatment
-----------------
* Device: McGrath Mac
* Device: Macintosh Laryngoscope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 Years capacity to consent Present written informed consent of the research participant Exclusion Criteria: Age <18 years Existing pregnancy Lack of consent inability to consent Difficult Airway / Defined Indications for awake intubation Participation in another study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: McGrath MAC<br>First pass success rate using the McGrath Mac | Device: McGrath Mac<br>* in a randomized order we evaluate the first pass success rate of the tracheal tube into the trachea.<br>|
| Experimental: Macintosh Laryngoscope<br>First pass success rate using the Macintosh laryngoscope | Device: Macintosh Laryngoscope<br>* in a randomized order we evaluate the first pass success rate of the tracheal tube into the trachea.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First pass Intubation success rate | successful tracheal intubation at the first attempt, compared to more than one attempt | at intubation in 60 seconds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to ventilation | From Insertion of the blase into the mouth until first ventilation | at intubation in 120 seconds | 
| Cormack and Lehane Classification | after insert the device the user describe the glottis visualisation | < 120 seconds | 
| Overall success rate | after two attempts using defined rescue techniques (e.g. rigid stylet, laryngeal mask) | < 120 seconds | 
| Intubation difficult score | Based on parameters known to be associated with difficult intubation (0=easy intubation to 5=difficult intubation | < 120 seconds | 
| adverse events | sore throat | after 24 hours | 
| complications | mucosal injury | < 120 seconds | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Videolaryngoscopy, Adverse Events, Airway Management