Evaluation of Video Laryngoscopy (Video Macintosh-blade) and Direct Laryngoscopy (EMMA-Study)

Study Overview
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Brief Summary
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A randomized controlled prospective study of laryngoscopy and intubation success comparing direct laryngoscopy and the McGrath® Mac videolaryngoscope.

Detailed Description
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As airway management continues to evolve the investigators do not have an accurate statement of the success of direct laryngoscopy in daily clinical practice. The use of videolaryngoscopy is increasing as a technique for rescue intubation as well as for elective intubation. Current airway management guidelines recommend video-assisted laryngoscopy as a choice for basic airway management. This is a proposed comparison study of a video laryngoscope, use in the daily anesthesia practice, and its likely increased success compared to direct laryngoscopy. An international, multi-center, prospective randomized comparative trial (RCT) is proposed testing the superiority of oral tracheal intubation with the McGrath® MAC versus conventional laryngoscope in adult patients under general anesthesia.

Official Title
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Evaluation of Video Laryngoscopy (Video Macintosh-blade) and Direct Laryngoscopy (EMMA-Study): A Prospective, Randomized Trial

Conditions
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Airway Morbidity

Intervention / Treatment
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* Device: the McGrath MAC
* Device: the Macintosh Laryngoscope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 Years No concurrent participation in another study capacity to consent Present written informed consent of the research participant Elective surgery under general anesthesia Exclusion Criteria: Age <18 years Existing pregnancy Lack of consent inability to consent emergency patients Emergency situations in the context of a Difficult Airway Management ASA classification> 3 situations where the possibility of accumulated gastric contents Participation in another study

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: McGrath MAC<br>tracheal intubation using the McGrath MAC | Device: the McGrath MAC<br>* in a randomised order we evaluate the success rate with the first attempt of the tracheal tube into the trachea.<br>|
| Experimental: Macintosh Laryngoscope<br>tracheal intubation using the Macintosh Laryngoscope | Device: the Macintosh Laryngoscope<br>* in a randomised order we evaluate the success rate with the first attempt of the tracheal tube into the trachea.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intubation success | successful tracheal intubation at the first attempt, compared to more than one attempt | at intubation; < 120 seconds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cormack and Lehane Classification | after insert the instrument the user describe the view of the laryngeal structure | < 120 seconds | 
| Percentage of glottic opening | airway visualization during intubation process | < 120 seconds | 
| Number of attempts | after two attempts using defined rescue techniques (e.g. rigid stylet, laryngeal mask) | < 120 seconds | 
| IDS (intubation difficult score) | intubation difficult score | < 120 seconds | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Airway management, video laryngoscope