NCT02292901

Brief Summary

Videolaryngoscopes become widely used. The aim of this study is to compare McGrath Mac videolaryngoscope to conventional MacIntosh laryngoscope in patients without known risk of difficult of mask ventilation and of tracheal intubation.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
158

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

2 active sites

Status
terminated

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 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

November 12, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 18, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

October 31, 2016

Status Verified

October 1, 2016

Enrollment Period

1 year

First QC Date

November 12, 2014

Last Update Submit

October 28, 2016

Conditions

Tracheal Intubation

Outcome Measures

Primary Outcomes (1)

  • Ease of tracheal intubation

    Ease of intubation is measured using the Intubation Difficulty Scale (Adnet et al. Anesthesiology 1997;87(6):1290-1297)

    1 hour

Secondary Outcomes (11)

  • Time to obtain the first capnogram (sec)

    one hour

  • Score of Cormak and Lehane modified by Yentis

    one hour

  • POGO (percentage of glottic opening) score

    one hour

  • Rate of use of alternative techniques for intubation

    one hour

  • Rate of esophageal intubation

    one hour

  • +6 more secondary outcomes

Study Arms (2)

Macintosh laryngoscope

ACTIVE COMPARATOR

Tracheal intubation will be performed using a Macintosh laryngoscope

Device: Macintosh laryngoscope

McGrath Mac videolaryngoscope

EXPERIMENTAL

Tracheal intubation will be performed using a McGrath Mac videolaryngoscope

Device: McGrath Mac videolaryngoscope

Interventions

Macintosh laryngoscopeDEVICE
Macintosh laryngoscope
McGrath Mac videolaryngoscopeDEVICE
McGrath Mac videolaryngoscope

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient scheduled for a general anesthesia with orotracheal intubation

You may not qualify if:

  • predictable risk of difficult mask ventilation or of difficult tracheal intubation
  • necessity of a rapid sequence induction
  • contra-indication to sufentanil, to propofol, or to atracurium
  • ENT, thoracic surgery, or intracranial surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institut Hospitalier Franco-Britannique

Levallois-Perret, Hauts de Seine, 92300, France

Location

Hopital Foch

Suresnes, Hauts de Seine, 92151, France

Location

Study Officials

  • Michel Chandon, MD

    Hopital Foch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2014

First Posted

November 18, 2014

Study Start

November 1, 2014

Primary Completion

November 1, 2015

Study Completion

May 1, 2016

Last Updated

October 31, 2016

Record last verified: 2016-10

Locations

FR(2)