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

• Sponsor: Johannes Gutenberg University Mainz (Other)
• Overall Status: Completed
• CT.gov ID: NCT02611986
• Collaborator: Western University, Canada (Other), Mutterhaus der Borromäerinnen, Germany (Other), Christophorus Hospital, Germany (Other)
• Enrollment: 2,466
• Location: 1
• Arms: 2
• Actual Duration (Months): 42.1
• Patients Per Site Per Month: 58.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Airway Morbidity	Device: the McGrath MAC; Device: the Macintosh Laryngoscope	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 2466 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of Video Laryngoscopy (Video Macintosh-blade) and Direct Laryngoscopy (EMMA-Study): A Prospective, Randomized Trial
• Actual Study Start Date: Nov 11, 2015
• Actual Primary Completion Date: May 7, 2019
• Actual Study Completion Date: May 14, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: McGrath MAC tracheal intubation using the McGrath MAC	Device: the McGrath MAC; in a randomised order we evaluate the success rate with the first attempt of the tracheal tube into the trachea.
Experimental: Macintosh Laryngoscope tracheal intubation using the Macintosh Laryngoscope	Device: the Macintosh Laryngoscope; in a randomised order we evaluate the success rate with the first attempt of the tracheal tube into the trachea.

Outcome Measures

Primary Outcome Measures

1. intubation success [at intubation; < 120 seconds]

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

Secondary Outcome Measures

1. Cormack and Lehane Classification [< 120 seconds]

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

2. Percentage of glottic opening [< 120 seconds]

   airway visualization during intubation process

3. Number of attempts [< 120 seconds]

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

4. IDS (intubation difficult score) [< 120 seconds]

   intubation difficult score

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University	Mainz	Rhineland-Palatinate	Germany	D55131

Sponsors and Collaborators

• Johannes Gutenberg University Mainz
• Western University, Canada
• Mutterhaus der Borromäerinnen, Germany
• Christophorus Hospital, Germany

Investigators

• Principal Investigator: Marc Kriege, MD, University JG, Mainz
• Principal Investigator: Rüdiger Noppens, MD,Phd, Western University

Study Documents (Full-Text)

None provided.

More Information

Publications

• Alvis BD, Hester D, Watson D, Higgins M, St Jacques P. Randomized controlled trial comparing the McGrath MAC video laryngoscope with the King Vision video laryngoscope in adult patients. Minerva Anestesiol. 2016 Jan;82(1):30-5. Epub 2015 Apr 17.
• Wallace CD, Foulds LT, McLeod GA, Younger RA, McGuire BE. A comparison of the ease of tracheal intubation using a McGrath MAC(®) laryngoscope and a standard Macintosh laryngoscope. Anaesthesia. 2015 Nov;70(11):1281-5. doi: 10.1111/anae.13209. Epub 2015 Sep 4.

• Responsible Party: Marc Kriege, MD, MD, Johannes Gutenberg University Mainz
• ClinicalTrials.gov Identifier: NCT02611986
• Other Study ID Numbers: JohannesGUE
• First Posted: Nov 23, 2015
• Last Update Posted: May 15, 2019
• Last Verified: May 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Marc Kriege, MD, MD, Johannes Gutenberg University Mainz: Airway management; video laryngoscope

Study Results

No Results Posted as of May 15, 2019