Clinical trial NCT04794764: Videolaryngoscopy Compared to Direct Laryngoscopy
Official title: Evaluation of Videolaryngoscopy (McGrath Mac) Compared to Direct Laryngoscopy for Rapid Sequence Intubation in Operating Room
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Aspiration of Gastric Contents
Keywords: Airway Management
Videolaryngoscopy
Adverse Events
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
Collaborators: name: Krankenhaus der Borromaerinnen Trier
name: University Medical Center Freiburg
name: BundeswehrZentralkrankenhaus Koblenz
name: Krankenhaus Hetzelstift
First posted: 2021-03-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: First pass Intubation success rate
timeFrame: at intubation in 60 seconds
Secondary outcomes:
measure: Time to ventilation
timeFrame: at intubation in 120 seconds
measure: Cormack and Lehane Classification
timeFrame: < 120 seconds
measure: Overall success rate
timeFrame: < 120 seconds
measure: Intubation difficult score
timeFrame: < 120 seconds
measure: adverse events
timeFrame: after 24 hours
measure: complications
timeFrame: < 120 seconds
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University
state: Rhineland-Palatinate
Study officials:
affiliation: University JG, Mainz
name: Marc Kriege, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.