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

May 13, 2019 updated by: Marc Kriege, MD, Johannes Gutenberg University Mainz

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

2466

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Germany, D55131
        • Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johannes Gutenberg University Mainz

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2015

Primary Completion (Actual)

May 7, 2019

Study Completion (Actual)

May 14, 2019

Study Registration Dates

First Submitted

November 15, 2015

First Submitted That Met QC Criteria

November 19, 2015

First Posted (Estimate)

November 23, 2015

Study Record Updates

Last Update Posted (Actual)

May 15, 2019

Last Update Submitted That Met QC Criteria

May 13, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • JohannesGUE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Airway Morbidity

Clinical Trials on the McGrath MAC

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Djibouti

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe