NCT04794764

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 12, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

July 24, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

1.9 years

First QC Date

March 9, 2021

Last Update Submit

January 3, 2024

Conditions

Pulmonary Aspiration of Gastric Contents

Keywords

Airway ManagementVideolaryngoscopyAdverse Events

Outcome Measures

Primary Outcomes (1)

  • First pass Intubation success rate

    successful tracheal intubation at the first attempt, compared to more than one attempt

    at intubation in 60 seconds

Secondary Outcomes (6)

  • Time to ventilation

    at intubation in 120 seconds

  • Cormack and Lehane Classification

    < 120 seconds

  • Overall success rate

    < 120 seconds

  • Intubation difficult score

    < 120 seconds

  • adverse events

    after 24 hours

  • +1 more secondary outcomes

Study Arms (2)

McGrath MAC

EXPERIMENTAL

First pass success rate using the McGrath Mac

Device: McGrath Mac

Macintosh Laryngoscope

EXPERIMENTAL

First pass success rate using the Macintosh laryngoscope

Device: Macintosh Laryngoscope

Interventions

McGrath MacDEVICE

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

McGrath MAC
Macintosh LaryngoscopeDEVICE

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

Macintosh Laryngoscope

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 Years
  • capacity to consent
  • Present written informed consent of the research participant

You may not qualify if:

  • Age \<18 years
  • Existing pregnancy
  • Lack of consent
  • inability to consent
  • Difficult Airway / Defined Indications for awake intubation
  • Participation in another study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Mainz, Rhineland-Palatinate, D55131, Germany

Location

Related Publications (1)

  • 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.

    PMID: 34615684DERIVED

MeSH Terms

Conditions

Respiratory Aspiration of Gastric Contents

Condition Hierarchy (Ancestors)

Laryngopharyngeal RefluxGastroesophageal RefluxEsophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesRespiratory AspirationRespiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Marc Kriege, MD, PhD

    University JG, Mainz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. med. habil. Marc Kriege

Study Record Dates

First Submitted

March 9, 2021

First Posted

March 12, 2021

Study Start

July 24, 2021

Primary Completion

July 1, 2023

Study Completion

August 31, 2023

Last Updated

January 5, 2024

Record last verified: 2024-01

Locations

DE(1)