Airway Morbidity Clinical Trial
— EMMAOfficial title:
Evaluation of Video Laryngoscopy (Video Macintosh-blade) and Direct Laryngoscopy (EMMA-Study): A Prospective, Randomized Trial
Verified date | May 2019 |
Source | Johannes Gutenberg University Mainz |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A randomized controlled prospective study of laryngoscopy and intubation success comparing direct laryngoscopy and the McGrath® Mac videolaryngoscope.
Status | Completed |
Enrollment | 2466 |
Est. completion date | May 14, 2019 |
Est. primary completion date | May 7, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University | Mainz | Rhineland-Palatinate |
Lead Sponsor | Collaborator |
---|---|
Johannes Gutenberg University Mainz | Christophorus Hospital, Germany, Mutterhaus der Borromäerinnen, Germany, Western University, Canada |
Germany,
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. — View Citation
Wallace CD, Foulds LT, McLeod GA, Younger RA, McGuire BE. A comparison of the ease of tracheal intubation using a McGrath MAC(®) laryngoscope and a standard Macintosh laryngoscope. Anaesthesia. 2015 Nov;70(11):1281-5. doi: 10.1111/anae.13209. Epub 2015 Sep 4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | intubation success | successful tracheal intubation at the first attempt, compared to more than one attempt | at intubation; < 120 seconds | |
Secondary | Cormack and Lehane Classification | after insert the instrument the user describe the view of the laryngeal structure | < 120 seconds | |
Secondary | Percentage of glottic opening | airway visualization during intubation process | < 120 seconds | |
Secondary | Number of attempts | after two attempts using defined rescue techniques (e.g. rigid stylet, laryngeal mask) | < 120 seconds | |
Secondary | IDS (intubation difficult score) | intubation difficult score | < 120 seconds |
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