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Completed

NCT Number: NCT04794764

Videolaryngoscopy Compared to Direct Laryngoscopy

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

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Key information

Conditions

Pulmonary Aspiration of Gastric Contents Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Laryngopharyngeal Reflux Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Aspiration of Gastric Contents Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University

Mainz, Rhineland-Palatinate, D55131, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

McGrath Mac

Device

in a randomized order we evaluate the first pass success rate of the tracheal tube into the trachea.

Macintosh laryngoscope

Device

in a randomized order we evaluate the first pass success rate of the tracheal tube into the trachea.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Johannes Gutenberg University Mainz

Other

Collaborators

  • BundeswehrZentralkrankenhaus Koblenz
  • Krankenhaus Hetzelstift
  • Krankenhaus der Borromaerinnen Trier
  • University Medical Center Freiburg

Registry information

Official study title

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

Acronym: LARA

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 12, 2021
Registry last updated
Jan 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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