Videolaryngoscopy Compared to Direct Laryngoscopy (LARA)

Johannes Gutenberg University (JGU)

Status: Completed

Conditions: Pulmonary Aspiration of Gastric Contents

Treatments: Device: Macintosh Laryngoscope; Device: McGrath Mac

Study type: Interventional

Funder types: Other

Identifiers

NCT04794764

JohannesGUV

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,000 participants in 2 patient groups

McGrath MAC

Experimental group

Description:

First pass success rate using the McGrath Mac

Treatment:

Device: McGrath Mac

Macintosh Laryngoscope

Experimental group

Description:

First pass success rate using the Macintosh laryngoscope

Treatment:

Device: Macintosh Laryngoscope