Pulmonary Aspiration of Gastric Contents
Conditions
Keywords
Airway Management, Videolaryngoscopy, Adverse Events
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.
Interventions
DEVICEMcGrath Mac
in a randomized order we evaluate the first pass success rate of the tracheal tube into the trachea.
DEVICEMacintosh Laryngoscope
in a randomized order we evaluate the first pass success rate of the tracheal tube into the trachea.
Sponsors
Krankenhaus der Borromaerinnen Trier
University Medical Center Freiburg
BundeswehrZentralkrankenhaus Koblenz
Krankenhaus Hetzelstift
Johannes Gutenberg University Mainz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First pass Intubation success rate | at intubation in 60 seconds | successful tracheal intubation at the first attempt, compared to more than one attempt |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cormack and Lehane Classification | < 120 seconds | after insert the device the user describe the glottis visualisation |
| Overall success rate | < 120 seconds | after two attempts using defined rescue techniques (e.g. rigid stylet, laryngeal mask) |
| Time to ventilation | at intubation in 120 seconds | From Insertion of the blase into the mouth until first ventilation |
| adverse events | after 24 hours | sore throat |
| complications | < 120 seconds | mucosal injury |
| Intubation difficult score | < 120 seconds | Based on parameters known to be associated with difficult intubation (0=easy intubation to 5=difficult intubation |
Countries
Germany
Outcome results
None listed