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

Johannes Gutenberg University (JGU)

Status: Completed

Conditions: Airway Morbidity

Treatments: Device: the McGrath MAC; Device: the Macintosh Laryngoscope

Study type: Interventional

Funder types: Other

Identifiers

NCT02611986

JohannesGUE

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,466 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

2,466 participants in 2 patient groups

McGrath MAC

Experimental group

Description:

tracheal intubation using the McGrath MAC

Treatment:

Device: the McGrath MAC

Macintosh Laryngoscope

Experimental group

Description:

tracheal intubation using the Macintosh Laryngoscope

Treatment:

Device: the Macintosh Laryngoscope