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Clinical Trials/NCT04794764
NCT04794764
Completed
Not Applicable

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

Johannes Gutenberg University Mainz1 site in 1 country1,000 target enrollmentJuly 24, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulmonary Aspiration of Gastric Contents
Sponsor
Johannes Gutenberg University Mainz
Enrollment
1000
Locations
1
Primary Endpoint
First pass Intubation success rate
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 24, 2021
End Date
August 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Johannes Gutenberg University Mainz
Responsible Party
Principal Investigator
Principal Investigator

Marc Kriege, MD

PD Dr. med. habil. Marc Kriege

Johannes Gutenberg University Mainz

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

Outcomes

Primary Outcomes

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

  • Cormack and Lehane Classification(< 120 seconds)
  • adverse events(after 24 hours)
  • Time to ventilation(at intubation in 120 seconds)
  • Overall success rate(< 120 seconds)
  • Intubation difficult score(< 120 seconds)
  • complications(< 120 seconds)

Study Sites (1)

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