Evaluation of Video Laryngoscopy (Video Macintosh-blade) and Direct Laryngoscopy (EMMA-Study): A Prospective, Randomized Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Airway Morbidity
- Sponsor
- Johannes Gutenberg University Mainz
- Enrollment
- 2466
- Locations
- 1
- Primary Endpoint
- intubation success
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
A randomized controlled prospective study of laryngoscopy and intubation success comparing direct laryngoscopy and the McGrath® Mac videolaryngoscope.
Detailed 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.
Investigators
Marc Kriege, MD
MD
Johannes Gutenberg University Mainz
Eligibility Criteria
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
Outcomes
Primary Outcomes
intubation success
Time Frame: at intubation; < 120 seconds
successful tracheal intubation at the first attempt, compared to more than one attempt
Secondary Outcomes
- Cormack and Lehane Classification(< 120 seconds)
- Percentage of glottic opening(< 120 seconds)
- Number of attempts(< 120 seconds)
- IDS (intubation difficult score)(< 120 seconds)