McGrath Mac VideoLaryngoscope vs the Macintosh Laryngoscope (MGM-Eval)

Randomised Controlled Trial of Intubation With the McGrath Mac VideoLaryngoscope vs the Macintosh Laryngoscope

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.

Study Overview

• Status: Terminated
• Conditions: Tracheal Intubation
• Intervention / Treatment: Device: Macintosh laryngoscope; Device: McGrath Mac videolaryngoscope

• Study Type: Interventional
• Enrollment (Actual): 158
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Hauts de Seine
    • Levallois-Perret, Hauts de Seine, France, 92300
      • Institut Hospitalier Franco-Britannique
    • Suresnes, Hauts de Seine, France, 92151
      • Hopital Foch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patient scheduled for a general anesthesia with orotracheal intubation

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Macintosh laryngoscope; Tracheal intubation will be performed using a Macintosh laryngoscope	Device: Macintosh laryngoscope
Experimental: McGrath Mac videolaryngoscope; Tracheal intubation will be performed using a McGrath Mac videolaryngoscope	Device: McGrath Mac videolaryngoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Incidence of arterial oxygen desaturation (SpO2 <92%)	one hour
Rate of failure of tracheal intubation	one hour
Rate of hemodynamic abnormality	one hour
Postoperative throat pain	one day
Postoperative hoarseness	one day
Questionnaire of Salditt-Isabel	one hour

Collaborators and Investigators

• Sponsor: Hopital Foch
• Investigators: Principal Investigator: Michel Chandon, MD, Hopital Foch

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: November 12, 2014
• First Submitted That Met QC Criteria: November 17, 2014
• First Posted (Estimate): November 18, 2014

Study Record Updates

• Last Update Posted (Estimate): October 31, 2016
• Last Update Submitted That Met QC Criteria: October 28, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 2013/42; 2013-A01307-38 (Other Identifier: ANSM)