Videolaryngoscopy Compared to Direct Laryngoscopy

Pulmonary Aspiration of Gastric Contents Clinical Trial

— LARA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04794764
• Other study ID #: JohannesGUV
• Status: Completed
• Phase: N/A
• Start date: July 24, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: January 2024
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: August 31, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pulmonary Aspiration of Gastric Contents
• Respiratory Aspiration of Gastric Contents

Intervention

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

Locations

Country	Name	City	State
Germany	Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University	Mainz	Rhineland-Palatinate

Sponsors (5)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz	Bundeswehrkrankenhaus Koblenz, Krankenhaus der Borromaerinnen Trier, Krankenhaus Hetzelstift, University Medical Center Freiburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First pass Intubation success rate	successful tracheal intubation at the first attempt, compared to more than one attempt	at intubation in 60 seconds
Secondary	Time to ventilation	From Insertion of the blase into the mouth until first ventilation	at intubation in 120 seconds
Secondary	Cormack and Lehane Classification	after insert the device the user describe the glottis visualisation	< 120 seconds
Secondary	Overall success rate	after two attempts using defined rescue techniques (e.g. rigid stylet, laryngeal mask)	< 120 seconds
Secondary	Intubation difficult score	Based on parameters known to be associated with difficult intubation (0=easy intubation to 5=difficult intubation	< 120 seconds
Secondary	adverse events	sore throat	after 24 hours
Secondary	complications	mucosal injury	< 120 seconds