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

N/ACompletedNCT02611986

Johannes Gutenberg University Mainz2,466 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

2,466

Conditions

Airway Morbidity

Interventions

the McGrath MACDEVICE

in a randomised order we evaluate the success rate with the first attempt of the tracheal tube into the trachea.

the Macintosh LaryngoscopeDEVICE

in a randomised order we evaluate the success rate with the first attempt of the tracheal tube into the trachea.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University

Mainz, Rhineland-Palatinate, Germany

Outcomes

Primary Outcomes

intubation success

successful tracheal intubation at the first attempt, compared to more than one attempt

Time frame: at intubation; < 120 seconds

Secondary Outcomes

Cormack and Lehane Classification

after insert the instrument the user describe the view of the laryngeal structure

Time frame: < 120 seconds

Percentage of glottic opening

airway visualization during intubation process

Time frame: < 120 seconds

Number of attempts

after two attempts using defined rescue techniques (e.g. rigid stylet, laryngeal mask)

Time frame: < 120 seconds

IDS (intubation difficult score)

intubation difficult score

Time frame: < 120 seconds

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.