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

NCT ID: NCT02611986

Last Updated: 2019-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2466 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-11

Study Completion Date

2019-05-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Airway Morbidity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

McGrath MAC

tracheal intubation using the McGrath MAC

Group Type EXPERIMENTAL

the McGrath MAC

Intervention Type DEVICE

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

Macintosh Laryngoscope

tracheal intubation using the Macintosh Laryngoscope

Group Type EXPERIMENTAL

the Macintosh Laryngoscope

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

the McGrath MAC

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

Intervention Type DEVICE

the Macintosh Laryngoscope

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Western University, Canada

OTHER

Sponsor Role collaborator

Mutterhaus der Borromäerinnen, Germany

UNKNOWN

Sponsor Role collaborator

Christophorus Hospital, Germany

UNKNOWN

Sponsor Role collaborator

Johannes Gutenberg University Mainz

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Marc Kriege, MD

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marc Kriege, MD

Role: PRINCIPAL_INVESTIGATOR

University JG, Mainz

Rüdiger Noppens, MD,Phd

Role: PRINCIPAL_INVESTIGATOR

Western University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Mainz, Rhineland-Palatinate, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

Wallace CD, Foulds LT, McLeod GA, Younger RA, McGuire BE. A comparison of the ease of tracheal intubation using a McGrath MAC((R)) laryngoscope and a standard Macintosh laryngoscope. Anaesthesia. 2015 Nov;70(11):1281-5. doi: 10.1111/anae.13209. Epub 2015 Sep 4.

Reference Type BACKGROUND
PMID: 26336853 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25881731 (View on PubMed)

Kriege M, Alflen C, Tzanova I, Schmidtmann I, Piepho T, Noppens RR. Evaluation of the McGrath MAC and Macintosh laryngoscope for tracheal intubation in 2000 patients undergoing general anaesthesia: the randomised multicentre EMMA trial study protocol. BMJ Open. 2017 Aug 21;7(8):e016907. doi: 10.1136/bmjopen-2017-016907.

Reference Type DERIVED
PMID: 28827261 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

JohannesGUE

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Comparison of Two Different Video Laryngoscopes
NCT06649526 ACTIVE_NOT_RECRUITING
Pediatric Endotracheal Intubation
NCT02291653 COMPLETED NA