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

Not Applicable

Completed

• Conditions: Airway Morbidity
• Interventions: Device: the McGrath MAC; Device: the Macintosh Laryngoscope

• Registration Number: NCT02611986
• Lead Sponsor: Johannes Gutenberg University Mainz

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2015-11-11
• Study First Submitted: 2015-11-15
• Study First Submitted QC: 2015-11-19
• Study First Posted: 2015-11-23
• Status Verified: 2019-05
• Primary Completion: 2019-05-07
• Last Update Submitted: 2019-05-13
• Study Completion: 2019-05-14
• Last Update Posted: 2019-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2466

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
McGrath MAC	the McGrath MAC	tracheal intubation using the McGrath MAC
Macintosh Laryngoscope	the Macintosh Laryngoscope	tracheal intubation using the Macintosh Laryngoscope

Primary Outcome Measures

Name	Time	Method
intubation success	at intubation; < 120 seconds	successful tracheal intubation at the first attempt, compared to more than one attempt

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University; 🇩🇪 Mainz, Rhineland-Palatinate, Germany