NCT02611986

Brief Summary

A randomized controlled prospective study of laryngoscopy and intubation success comparing direct laryngoscopy and the McGrath® Mac videolaryngoscope.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,466

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

Longer than P75 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

Study Start

First participant enrolled

November 11, 2015

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 23, 2015

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2019

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2019

Completed
Last Updated

May 15, 2019

Status Verified

May 1, 2019

Enrollment Period

3.5 years

First QC Date

November 15, 2015

Last Update Submit

May 13, 2019

Conditions

Airway Morbidity

Keywords

Airway managementvideo laryngoscope

Outcome Measures

Primary Outcomes (1)

  • intubation success

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

    at intubation; < 120 seconds

Secondary Outcomes (4)

  • Cormack and Lehane Classification

    < 120 seconds

  • Percentage of glottic opening

    < 120 seconds

  • Number of attempts

    < 120 seconds

  • IDS (intubation difficult score)

    < 120 seconds

Study Arms (2)

McGrath MAC

EXPERIMENTAL

tracheal intubation using the McGrath MAC

Device: the McGrath MAC

Macintosh Laryngoscope

EXPERIMENTAL

tracheal intubation using the Macintosh Laryngoscope

Device: the Macintosh Laryngoscope

Interventions

the McGrath MACDEVICE

in a randomised order we evaluate the success rate with the first attempt of the tracheal tube into the trachea.

McGrath MAC
the Macintosh LaryngoscopeDEVICE

in a randomised order we evaluate the success rate with the first attempt 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 No concurrent participation in another study
  • capacity to consent
  • Present written informed consent of the research participant
  • Elective surgery under general anesthesia

You may not qualify if:

  • Age \<18 years
  • Existing pregnancy
  • Lack of consent
  • inability to consent
  • emergency patients
  • Emergency situations in the context of a Difficult Airway Management
  • ASA classification\> 3
  • situations where the possibility of accumulated gastric contents
  • 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 (3)

  • Wallace CD, Foulds LT, McLeod GA, Younger RA, McGuire BE. A comparison of the ease of tracheal intubation using a McGrath MAC((R)) laryngoscope and a standard Macintosh laryngoscope. Anaesthesia. 2015 Nov;70(11):1281-5. doi: 10.1111/anae.13209. Epub 2015 Sep 4.

    PMID: 26336853BACKGROUND

  • Alvis BD, Hester D, Watson D, Higgins M, St Jacques P. Randomized controlled trial comparing the McGrath MAC video laryngoscope with the King Vision video laryngoscope in adult patients. Minerva Anestesiol. 2016 Jan;82(1):30-5. Epub 2015 Apr 17.

    PMID: 25881731BACKGROUND

  • Kriege M, Alflen C, Tzanova I, Schmidtmann I, Piepho T, Noppens RR. Evaluation of the McGrath MAC and Macintosh laryngoscope for tracheal intubation in 2000 patients undergoing general anaesthesia: the randomised multicentre EMMA trial study protocol. BMJ Open. 2017 Aug 21;7(8):e016907. doi: 10.1136/bmjopen-2017-016907.

    PMID: 28827261DERIVED

Study Officials

  • Marc Kriege, MD

    University JG, Mainz

    PRINCIPAL INVESTIGATOR

  • Rüdiger Noppens, MD,Phd

    Western University

    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
MD

Study Record Dates

First Submitted

November 15, 2015

First Posted

November 23, 2015

Study Start

November 11, 2015

Primary Completion

May 7, 2019

Study Completion

May 14, 2019

Last Updated

May 15, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)