McGrath Mac Videolaryngoscope Versus Macintosh Laryngoscope for Orotracheal Intubation in Critical Care Unit

Not Applicable

Completed

• Conditions: Intratracheal Intubation in Critical Care
• Interventions: Device: Standard laryngoscope; Device: Videolaryngoscope

• Registration Number: NCT02413723
• Lead Sponsor: Centre Hospitalier Departemental Vendee

Brief Summary

The aim of this study is to demonstrate that the rate of successful orotracheal intubation at first laryngoscopy will be higher in patients intubated with McGrath Mac videolaryngoscope compared to patients intubated with classical Macintosh laryngoscope in patients requiring an orotracheal intubation in ICU.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-28
• Study First Submitted QC: 2015-04-09
• Study First Posted: 2015-04-10
• Study Start: 2015-05
• Primary Completion: 2015-11
• Study Completion: 2016-02
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-14
• Last Update Posted: 2016-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 371

Inclusion Criteria

• Requiring orotracheal intubation

Exclusion Criteria

• Contraindication to orotracheal intubation
• Time too short to allow inclusion and randomisation of patient (particularly cardiac arrest)
• Minor (<18 )
• Pregnant, parturient , or breast-feeding woman
• Patient hospitalized without consent and/or deprived of liberty by court's decision
• Patient under guardianship or curators
• Lack of social insurance
• Lack of informed consent
• Concomitant inclusion in a trial whose primary endpoint focuses on intubation procedure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard laryngoscope	Standard laryngoscope	Macintosh laryngoscope will be used for laryngoscopy for patient's intubation
Videolaryngoscope McGrath Mac	Videolaryngoscope	McGrath Mac videolaryngoscope will be used for laryngoscopy for patient's intubation

Primary Outcome Measures

Name	Time	Method
Proportion of successful orotracheal intubation at first laryngoscopy	intubation procedure, an expected average of 15 minutes	Number of successful intubation at first laryngoscopy in one arm/number of included patients in the same arm.

Secondary Outcome Measures

Name	Time	Method
Proportion of successful orotracheal intubation all laryngoscopies pooled	intubation procedure, an expected average of 15 minutes
Time to successful orotracheal intubation	intubation procedure, an expected average of 15 minutes	Defined by the time between the beginning of induction (injection of anesthetic drugs) and the time of confirmation of the intratracheal nature of the endotracheal tube (defined as apparition of first inflexion on the expired carbon dioxide curve)

Trial Locations

Locations (7)

CHU Louis Mourier; 🇫🇷 Colombes, France

CHD Vendee; 🇫🇷 La Roche Sur Yon, France

CHU Orleans; 🇫🇷 Orleans, France

CHU Saint Louis; 🇫🇷 Paris, France

CHU Tours; 🇫🇷 Tours, France

CHU Paris Cochin; 🇫🇷 Paris, France

CHU Strasbourg Nouvel Hôpital Civil; 🇫🇷 Strasbourg, France