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Videolaryngoscopy Compared to Direct Laryngoscopy (LARA)

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ClinicalTrials.gov Identifier: NCT04794764
Recruitment Status : Recruiting
First Posted : March 12, 2021
Last Update Posted : March 3, 2022
Sponsor:
Collaborators:
Krankenhaus der Borromaerinnen Trier
University Medical Center Freiburg
Bundeswehrkrankenhaus Koblenz
Krankenhaus Hetzelstift
Information provided by (Responsible Party):
Marc Kriege, MD, Johannes Gutenberg University Mainz

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

Condition or disease Intervention/treatment Phase
Pulmonary Aspiration of Gastric Contents Device: McGrath Mac Device: Macintosh Laryngoscope Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Videolaryngoscopy (McGrath Mac) Compared to Direct Laryngoscopy for Rapid Sequence Intubation in Operating Room
Actual Study Start Date : July 24, 2021
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : July 31, 2022
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Time to ventilation [ Time Frame: at intubation in 120 seconds ]
    From Insertion of the blase into the mouth until first ventilation

  2. Cormack and Lehane Classification [ Time Frame: < 120 seconds ]
    after insert the device the user describe the glottis visualisation

  3. Overall success rate [ Time Frame: < 120 seconds ]
    after two attempts using defined rescue techniques (e.g. rigid stylet, laryngeal mask)

  4. Intubation difficult score [ Time Frame: < 120 seconds ]
    Based on parameters known to be associated with difficult intubation (0=easy intubation to 5=difficult intubation

  5. adverse events [ Time Frame: after 24 hours ]
    sore throat

  6. complications [ Time Frame: < 120 seconds ]
    mucosal injury


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04794764


Contacts
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Contact: Marc Kriege, MD, PhD 00496131170 MaKriege@uni-mainz.de

Locations
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Germany
Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University Recruiting
Mainz, Rhineland-Palatinate, Germany, D55131
Contact: Marc Kriege, MD    00496131170      
Sponsors and Collaborators
Johannes Gutenberg University Mainz
Krankenhaus der Borromaerinnen Trier
University Medical Center Freiburg
Bundeswehrkrankenhaus Koblenz
Krankenhaus Hetzelstift
Investigators
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Principal Investigator: Marc Kriege, MD, PhD University JG, Mainz
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Marc Kriege, MD, PD Dr. med. habil. Marc Kriege, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT04794764    
Other Study ID Numbers: JohannesGUV
First Posted: March 12, 2021    Key Record Dates
Last Update Posted: March 3, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marc Kriege, MD, Johannes Gutenberg University Mainz:
Airway Management
Videolaryngoscopy
Adverse Events
Additional relevant MeSH terms:
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Respiratory Aspiration of Gastric Contents
Laryngopharyngeal Reflux
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
 Gastrointestinal Diseases
Digestive System Diseases
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes