Videolaryngoscopy Compared to Direct Laryngoscopy (LARA)

Evaluation of Videolaryngoscopy (McGrath Mac) Compared to Direct Laryngoscopy for Rapid Sequence Intubation in Operating Room

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

Study Overview

• Status: Completed
• Conditions: Pulmonary Aspiration of Gastric Contents
• Intervention / Treatment: Device: McGrath Mac; Device: Macintosh Laryngoscope

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.

• Study Type: Interventional
• Enrollment (Actual): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marc Kriege, MD, PhD; Phone Number: 00496131170; Email: MaKriege@uni-mainz.de

Study Locations

• Germany
  • Rhineland-Palatinate
    • Mainz, Rhineland-Palatinate, Germany, D55131
      • Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: McGrath MAC; First pass success rate using the McGrath Mac	Device: McGrath Mac; in a randomized order we evaluate the first pass success rate of the tracheal tube into the trachea.
Experimental: Macintosh Laryngoscope; First pass success rate using the Macintosh laryngoscope	Device: Macintosh Laryngoscope; in a randomized order we evaluate the first pass success rate of the tracheal tube into the trachea.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Johannes Gutenberg University Mainz
• Collaborators: University Medical Center Freiburg; Krankenhaus der Borromaerinnen Trier; Bundeswehrkrankenhaus Koblenz; Krankenhaus Hetzelstift
• Investigators: Principal Investigator: Marc Kriege, MD, PhD, University JG, Mainz

Publications and helpful links

General Publications

• Kriege M, Lang P, Lang C, Pirlich N, Griemert EV, Heid F, Wittenmeier E, Schmidtmann I, Schmidbauer W, Janig C, Jungbecker J, Kunitz O, Strate M, Schmutz A. Anaesthesia protocol evaluation of the videolaryngoscopy with the McGrath MAC and direct laryngoscopy for tracheal intubation in 1000 patients undergoing rapid sequence induction: the randomised multicentre LARA trial study protocol. BMJ Open. 2021 Oct 6;11(10):e052977. doi: 10.1136/bmjopen-2021-052977.

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2021
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: March 9, 2021
• First Submitted That Met QC Criteria: March 9, 2021
• First Posted (Actual): March 12, 2021

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Videolaryngoscopy; Airway Management; Adverse Events
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux; Laryngopharyngeal Reflux; Respiratory Aspiration; Respiratory Aspiration of Gastric Contents
• Other Study ID Numbers: JohannesGUV

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No