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

• Published in: BMJ open 2017-08, Vol.7 (8), p.e016907-e016907
• Main Authors: Kriege, Marc, Alflen, Christian, Tzanova, Irene, Schmidtmann, Irene, Piepho, Tim, Noppens, Ruediger R
• Format: Article
• Language: English
• Subjects: Airway management; Anaesthesia; Anesthesia; Anesthesia, General; Anesthesiology; Evidence-based medicine; Female; Germany; Glottis; Humans; Intensive care; Intubation; Intubation, Intratracheal - instrumentation; Laryngoscopes - statistics & numerical data; Laryngoscopy - instrumentation; Male; Prospective Studies; Regression Analysis; Research Design; Success; Video-Assisted Surgery - instrumentation
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2017-016907

IntroductionThe 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 analysisThe 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 disseminationThe 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 numberClinicalTrials.gov NCT 02611986; pre-results.