McGrath Mac VideoLaryngoscope vs the Macintosh Laryngoscope

Tracheal Intubation Clinical Trial

— MGM-Eval  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02292901
• Other study ID #: 2013/42
• Secondary ID: 2013-A01307-38
• Status: Terminated
• Phase: N/A
• First received: November 12, 2014
• Last updated: October 28, 2016
• Start date: November 2014
• Est. completion date: May 2016

Study information

• Verified date: October 2016
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 158
• Est. completion date: May 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tracheal Intubation

Intervention

Device:
• Macintosh laryngoscope

• McGrath Mac videolaryngoscope

Locations

Country	Name	City	State
France	Institut Hospitalier Franco-Britannique	Levallois-Perret	Hauts de Seine
France	Hopital Foch	Suresnes	Hauts de Seine

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Time to obtain the first capnogram (sec)		one hour	No
Secondary	Score of Cormak and Lehane modified by Yentis		one hour	No
Secondary	POGO (percentage of glottic opening) score		one hour	No
Secondary	Rate of use of alternative techniques for intubation		one hour	No
Secondary	Rate of esophageal intubation		one hour	No
Secondary	Incidence of arterial oxygen desaturation (SpO2 <92%)		one hour	No
Secondary	Rate of failure of tracheal intubation		one hour	No
Secondary	Rate of hemodynamic abnormality		one hour	No
Secondary	Postoperative throat pain		one day	No
Secondary	Postoperative hoarseness		one day	No
Secondary	Questionnaire of Salditt-Isabel		one hour	No