Videolaryngoscopy Compared to Direct Laryngoscopy

Johannes Gutenberg University Mainz1,000 enrolled

Overview

Videolaryngoscope (Macintosh-type blade) compared with direct laryngoscopy for rapid sequence intubation in the operating room

Video laryngoscopy (VL) is a etablished method of achieving tracheal intubation and there is evidence to show that visualisation of larynx can be improved using VL in failed tracheal Intubation (NAP 4 Report). VL has been shown to improve first attempt success compared to direct laryngoscopy in many clinical settings including intensive care unit (ICU) and emergency department (ED). This is a proposed comparison study of a VL, use in patients with a high risk for pulmonary Aspiration and requiring tracheal Intubation. An national, multi-center, prospective randomized comparative trial is proposed testing the superiority of oral tracheal intubation with the McGrath® MAC versus conventional laryngoscope in adult patients under general anesthesia.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,000

Conditions

Pulmonary Aspiration of Gastric Contents

Interventions

McGrath MacDEVICE

in a randomized order we evaluate the first pass success rate of the tracheal tube into the trachea.

Macintosh LaryngoscopeDEVICE

in a randomized order we evaluate the first pass success rate of the tracheal tube into the trachea.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 18 Years * capacity to consent * Present written informed consent of the research participant Exclusion Criteria: * Age \<18 years * Existing pregnancy * Lack of consent * inability to consent * Difficult Airway / Defined Indications for awake intubation * Participation in another study

Locations (1)

Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University

Mainz, Rhineland-Palatinate, Germany

Outcomes

Primary Outcomes

First pass Intubation success rate

successful tracheal intubation at the first attempt, compared to more than one attempt

Time frame: at intubation in 60 seconds

Secondary Outcomes

Time to ventilation

From Insertion of the blase into the mouth until first ventilation

Time frame: at intubation in 120 seconds

Cormack and Lehane Classification

after insert the device the user describe the glottis visualisation

Time frame: < 120 seconds

Overall success rate

after two attempts using defined rescue techniques (e.g. rigid stylet, laryngeal mask)

Time frame: < 120 seconds

Intubation difficult score

Based on parameters known to be associated with difficult intubation (0=easy intubation to 5=difficult intubation

Time frame: < 120 seconds

adverse events

sore throat

Time frame: after 24 hours

complications

mucosal injury

Time frame: < 120 seconds

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.