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Completed

NCT Number: NCT02611986

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

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

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Key information

Conditions

Airway Morbidity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Mainz, Rhineland-Palatinate, D55131, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

the McGrath MAC

Device

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

the Macintosh laryngoscope

Device

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

Primary outcomes

  1. intubation success

    Time frame: at intubation; < 120 seconds

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

Secondary outcomes

  1. Cormack and Lehane Classification

    Time frame: < 120 seconds

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

  2. Percentage of glottic opening

    Time frame: < 120 seconds

    airway visualization during intubation process

  3. Number of attempts

    Time frame: < 120 seconds

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

  4. IDS (intubation difficult score)

    Time frame: < 120 seconds

    intubation difficult score

Sponsors and collaborators

Lead sponsor

Johannes Gutenberg University Mainz

Other

Collaborators

  • Christophorus Hospital, Germany
  • Mutterhaus der Borromäerinnen, Germany
  • Western University, Canada

Registry information

Official study title

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

Acronym: EMMA

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Nov 23, 2015
Registry last updated
May 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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