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

Airway Morbidity Clinical Trial

— EMMA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02611986
• Other study ID #: JohannesGUE
• Status: Completed
• Phase: N/A
• Start date: November 11, 2015
• Est. completion date: May 14, 2019

Study information

• Verified date: May 2019
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Airway Morbidity

Intervention

Device:
• the McGrath MAC
in a randomised order we evaluate the success rate with the first attempt of the tracheal tube into the trachea.
• the Macintosh Laryngoscope
in a randomised order we evaluate the success rate with the first attempt of the tracheal tube into the trachea.

Locations

Country	Name	City	State
Germany	Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University	Mainz	Rhineland-Palatinate

Sponsors (4)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz	Christophorus Hospital, Germany, Mutterhaus der Borromäerinnen, Germany, Western University, Canada

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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

Outcome

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