Videolaryngoscopy Compared to Direct Laryngoscopy

Overview

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

Full Title of Study: “Evaluation of Videolaryngoscopy (McGrath Mac) Compared to Direct Laryngoscopy for Rapid Sequence Intubation in Operating Room”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 1, 2023

Detailed Description

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.

Interventions

  • Device: McGrath Mac
    • in a randomized order we evaluate the first pass success rate of the tracheal tube into the trachea.
  • Device: Macintosh Laryngoscope
    • in a randomized order we evaluate the first pass success rate of the tracheal tube into the trachea.

Arms, Groups and Cohorts

  • Experimental: McGrath MAC
    • First pass success rate using the McGrath Mac
  • Experimental: Macintosh Laryngoscope
    • First pass success rate using the Macintosh laryngoscope

Clinical Trial Outcome Measures

Primary Measures

  • First pass Intubation success rate
    • Time Frame: at intubation in 60 seconds
    • successful tracheal intubation at the first attempt, compared to more than one attempt

Secondary Measures

  • Time to ventilation
    • Time Frame: at intubation in 120 seconds
    • From Insertion of the blase into the mouth until first ventilation
  • Cormack and Lehane Classification
    • Time Frame: < 120 seconds
    • after insert the device the user describe the glottis visualisation
  • Overall success rate
    • Time Frame: < 120 seconds
    • after two attempts using defined rescue techniques (e.g. rigid stylet, laryngeal mask)
  • Intubation difficult score
    • Time Frame: < 120 seconds
    • Based on parameters known to be associated with difficult intubation (0=easy intubation to 5=difficult intubation
  • adverse events
    • Time Frame: after 24 hours
    • sore throat
  • complications
    • Time Frame: < 120 seconds
    • mucosal injury

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Johannes Gutenberg University Mainz
  • Collaborator
    • Krankenhaus der Borromaerinnen Trier
  • Provider of Information About this Clinical Study
    • Principal Investigator: Marc Kriege, MD, PD Dr. med. habil. Marc Kriege – Johannes Gutenberg University Mainz
  • Overall Official(s)
    • Marc Kriege, MD, PhD, Principal Investigator, University JG, Mainz

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