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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02611986
Acronym
EMMA
Enrollment
2466
Registered
2015-11-23
Start date
2015-11-11
Completion date
2019-05-14
Last updated
2019-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Morbidity

Keywords

Airway management, video laryngoscope

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.

Interventions

DEVICEthe McGrath MAC

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

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

Sponsors

Western University, Canada
CollaboratorOTHER
Mutterhaus der Borromäerinnen, Germany
CollaboratorUNKNOWN
Christophorus Hospital, Germany
CollaboratorUNKNOWN
Johannes Gutenberg University Mainz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
intubation successat intubation; < 120 secondssuccessful tracheal intubation at the first attempt, compared to more than one attempt

Secondary

MeasureTime frameDescription
Cormack and Lehane Classification< 120 secondsafter insert the instrument the user describe the view of the laryngeal structure
Percentage of glottic opening< 120 secondsairway visualization during intubation process
Number of attempts< 120 secondsafter two attempts using defined rescue techniques (e.g. rigid stylet, laryngeal mask)
IDS (intubation difficult score)< 120 secondsintubation difficult score

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026