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Videolaryngoscopy Compared to Direct Laryngoscopy (LARA)

Primary Purpose

Pulmonary Aspiration of Gastric Contents

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
McGrath Mac
Macintosh Laryngoscope
Sponsored by
Johannes Gutenberg University Mainz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Aspiration of Gastric Contents focused on measuring Airway Management, Videolaryngoscopy, Adverse Events

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

McGrath MAC

Macintosh Laryngoscope

Arm Description

First pass success rate using the McGrath Mac

First pass success rate using the Macintosh laryngoscope

Outcomes

Primary Outcome Measures

First pass Intubation success rate
successful tracheal intubation at the first attempt, compared to more than one attempt

Secondary Outcome Measures

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

Full Information

First Posted
March 9, 2021
Last Updated
January 24, 2023
Sponsor
Johannes Gutenberg University Mainz
Collaborators
Krankenhaus der Borromaerinnen Trier, University Medical Center Freiburg, Bundeswehrkrankenhaus Koblenz, Krankenhaus Hetzelstift
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1. Study Identification

Unique Protocol Identification Number
NCT04794764
Brief Title
Videolaryngoscopy Compared to Direct Laryngoscopy
Acronym
LARA
Official Title
Evaluation of Videolaryngoscopy (McGrath Mac) Compared to Direct Laryngoscopy for Rapid Sequence Intubation in Operating Room
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 24, 2021 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johannes Gutenberg University Mainz
Collaborators
Krankenhaus der Borromaerinnen Trier, University Medical Center Freiburg, Bundeswehrkrankenhaus Koblenz, Krankenhaus Hetzelstift

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Aspiration of Gastric Contents
Keywords
Airway Management, Videolaryngoscopy, Adverse Events

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
McGrath MAC
Arm Type
Experimental
Arm Description
First pass success rate using the McGrath Mac
Arm Title
Macintosh Laryngoscope
Arm Type
Experimental
Arm Description
First pass success rate using the Macintosh laryngoscope
Intervention Type
Device
Intervention Name(s)
McGrath Mac
Intervention Description
in a randomized order we evaluate the first pass success rate of the tracheal tube into the trachea.
Intervention Type
Device
Intervention Name(s)
Macintosh Laryngoscope
Intervention Description
in a randomized order we evaluate the first pass success rate of the tracheal tube into the trachea.
Primary Outcome Measure Information:
Title
First pass Intubation success rate
Description
successful tracheal intubation at the first attempt, compared to more than one attempt
Time Frame
at intubation in 60 seconds
Secondary Outcome Measure Information:
Title
Time to ventilation
Description
From Insertion of the blase into the mouth until first ventilation
Time Frame
at intubation in 120 seconds
Title
Cormack and Lehane Classification
Description
after insert the device the user describe the glottis visualisation
Time Frame
< 120 seconds
Title
Overall success rate
Description
after two attempts using defined rescue techniques (e.g. rigid stylet, laryngeal mask)
Time Frame
< 120 seconds
Title
Intubation difficult score
Description
Based on parameters known to be associated with difficult intubation (0=easy intubation to 5=difficult intubation
Time Frame
< 120 seconds
Title
adverse events
Description
sore throat
Time Frame
after 24 hours
Title
complications
Description
mucosal injury
Time Frame
< 120 seconds

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marc Kriege, MD, PhD
Phone
00496131170
Email
MaKriege@uni-mainz.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Kriege, MD, PhD
Organizational Affiliation
University JG, Mainz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University
City
Mainz
State/Province
Rhineland-Palatinate
ZIP/Postal Code
D55131
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Kriege, MD
Phone
00496131170

12. IPD Sharing Statement

Citations:
PubMed Identifier
34615684
Citation
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.
Results Reference
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Videolaryngoscopy Compared to Direct Laryngoscopy

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