Evaluation of the McGrath MAC and Macintosh laryngoscope for tracheal intubation in 2000 patients undergoing general anaesthesia: the randomised multicentre EMMA trial study protocol

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Abstract

Introduction

The direct laryngoscopy technique using a Macintosh blade is the first choice globally for most anaesthetists. In case of an unanticipated difficult airway, the complication rate increases with the number of intubation attempts. Recently, McGrath MAC (McGrath) video laryngoscopy has become a widely accepted method for securing an airway by tracheal intubation because it allows the visualisation of the glottis without a direct line of sight. Several studies and case reports have highlighted the benefit of the video laryngoscope in the visualisation of the glottis and found it to be superior in difficult intubation situations. The aim of this study was to compare the first-pass intubation success rate using the (McGrath) video laryngoscope compared with conventional direct laryngoscopy in surgical patients.

Methods and analysis

The EMMA trial is a multicentre, open-label, patient-blinded, randomised controlled trial. Consecutive patients requiring tracheal intubation are randomly allocated to either the McGrath video laryngoscope or direct laryngoscopy using the Macintosh laryngoscope. The expected rate of successful first-pass intubation is 95% in the McGrath group and 90% in the Macintosh group. Each group must include a total of 1000 patients to achieve 96% power for detecting a difference at the 5% significance level. Successful intubation with the first attempt is the primary endpoint. The secondary endpoints are the time to intubation, attempts for successful intubation, the necessity of alternatives, visualisation of the glottis using the Cormack & Lehane score and percentage of glottic opening score and definite complications.

Ethics and dissemination

The project was approved by the local ethics committee of the Medical Association of the Rhineland Palatine state and Westphalia-Lippe. The results of this study will be made available in the form of manuscripts for publication and presentations at national and international meetings.

Trial registration number

ClinicalTrials.gov NCT 02611986; pre-results.

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Most cited references 33

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Association between repeated intubation attempts and adverse events in emergency departments: an analysis of a multicenter prospective observational study.

Kohei Hasegawa, Kazuaki Shigemitsu, Yusuke Hagiwara … (2012)

Although repeated intubation attempts are believed to contribute to patient morbidity, only limited data characterize the association between the number of emergency department (ED) laryngoscopic attempts and adverse events. We seek to determine whether multiple ED intubation attempts are associated with an increased risk of adverse events. We conducted an analysis of a multicenter prospective registry of 11 Japanese EDs between April 2010 and September 2011. All patients undergoing emergency intubation with direct laryngoscopy as the initial device were included. The primary exposure was multiple intubation attempts, defined as intubation efforts requiring greater than or equal to 3 laryngoscopies. The primary outcome measure was the occurrence of intubation-related adverse events in the ED, including cardiac arrest, dysrhythmia, hypotension, hypoxemia, unrecognized esophageal intubation, regurgitation, airway trauma, dental or lip trauma, and mainstem bronchus intubation. Of 2,616 patients, 280 (11%) required greater than or equal to 3 intubation attempts. Compared with patients requiring 2 or fewer intubation attempts, patients undergoing multiple attempts exhibited a higher adverse event rate (35% versus 9%). After adjusting for age, sex, principal indication, method, medication, and operator characteristics, intubations requiring multiple attempts were associated with an increased odds of adverse events (odds ratio 4.5; 95% confidence interval 3.4 to 6.1). In this large Japanese multicenter study of ED patients undergoing intubation, we found that multiple intubation attempts were independently associated with increased adverse events. Copyright © 2012. Published by Mosby, Inc.

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Comparison of video laryngoscopy versus direct laryngoscopy during urgent endotracheal intubation: a randomized controlled trial.

Michael Silverberg, Nan Li, Samuel Acquah … (2015)

In the critically ill undergoing urgent endotracheal intubation by direct laryngoscopy, multiple attempts are often required with a higher complication rate due to the urgency, uncontrolled setting, comorbidities, and variability in expertise of operators. We hypothesized that Glidescope video laryngoscopy would be superior to direct laryngoscopy during urgent endotracheal intubation.

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Laryngoscopic intubation: learning and performance.

Erin K MacQuarrie, Orlando Hung, Saul Pytka … (2002)

Many healthcare professionals are trained in direct laryngoscopic tracheal intubation (LEI), which is a potentially lifesaving procedure. This study attempts to determine the number of successful LEI exposures required during training to assure competent performance, with special emphasis on defining competence itself. Analyses were based on a longitudinal study of novices under training conditions in the operating room. The progress of 438 LEIs performed by the 20 nonanesthesia trainees was monitored by observation and videotape analysis. Eighteen additional LEIs were performed by experienced anesthesiologists to define the standard. A generalized linear, mixed-modelling approach was used to identify key aspects of effective training and performance. The number of tracheal intubations that the trainees were required to perform before acquiring expertise in LEI was estimated. Subjects performed between 18 and 35 laryngoscopic intubations. However, statistical modeling indicates that a 90% probability of a "good intubation" required 47 attempts. Proper insertion and lifting of the laryngoscope were crucial to "good" or "competent" performance of LEI. Traditional features, such as proper head and neck positions, were found to be less important under the study conditions. This study determined that traditional LEI teaching for nonanesthesia personnel using manikin alone is inadequate. A reevaluation of current standards in LEI teaching for nonanesthesia is required.

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Author and article information

Journal

Journal ID (nlm-ta): BMJ Open

Journal ID (iso-abbrev): BMJ Open

Journal ID (hwp): bmjopen

Journal ID (publisher-id): bmjopen

Title: BMJ Open

Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )

ISSN (Electronic): 2044-6055

Publication date Collection: 2017

Publication date (Electronic): 21 August 2017

Volume: 7

Issue: 8

Electronic Location Identifier: e016907

Affiliations

[1 ] departmentDepartment of Anaesthesiology , University Medical Centre of the Johannes, Gutenberg University , Mainz, Germany

[2 ] departmentDepartment of Anaesthesiology , Christophorus Hospital , Coesfeld, Germany

[3 ] Institute of Medical Biostatistics, Epidemiology and Informatics, University Medical Centre of the Johannes Gutenberg University , Mainz, Germany

[4 ] departmentDepartment of Anesthesia and Perioperative Medicine , Western University , London, Ontario, Canada

Author notes

[Correspondence to ] Dr Ruediger R Noppens; ruediger.noppens@ 123456lhsc.on.ca

Article

Publisher ID: bmjopen-2017-016907

DOI: 10.1136/bmjopen-2017-016907

PMC ID: 5724220

PubMed ID: 28827261

SO-VID: fa91942d-407c-407d-b1d7-0a25370a47e9

License:

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

History

Date received : 17 March 2017

Date revision received : 29 May 2017

Date accepted : 06 June 2017

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ScienceOpen disciplines: Medicine

Keywords: adult anaesthesia,airway management,video laryngoscope,macintosh laryngoscope,difficult airwayd,intubation

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ScienceOpen disciplines: Medicine

Keywords: adult anaesthesia, airway management, video laryngoscope, macintosh laryngoscope, difficult airwayd, intubation

Evaluation of the McGrath MAC and Macintosh laryngoscope for tracheal intubation in 2000 patients undergoing general anaesthesia: the randomised multicentre EMMA trial study protocol

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Abstract

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Related collections

Herbal Medicines Journal (Herb Med J)

Most cited references 33

Association between repeated intubation attempts and adverse events in emergency departments: an analysis of a multicenter prospective observational study.

Comparison of video laryngoscopy versus direct laryngoscopy during urgent endotracheal intubation: a randomized controlled trial.

Laryngoscopic intubation: learning and performance.

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