Clinical trial NCT02413723: McGrath Mac Videolaryngoscope Versus Macintosh Laryngoscope for Orotracheal Intubation in Critical Care Unit
Official title: McGrath Mac Videolaryngoscope Versus Macintosh Laryngoscope for Orotracheal Intubation in Critical Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intratracheal Intubation in Critical Care
Keywords: intubation
critical care
laryngoscope
videolaryngoscope
intratracheal
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
Collaborators: name: Nantes University Hospital
First posted: 2015-04-10
Enrollment: 371
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of successful orotracheal intubation at first laryngoscopy
timeFrame: intubation procedure, an expected average of 15 minutes
Secondary outcomes:
measure: Proportion of successful orotracheal intubation all laryngoscopies pooled
timeFrame: intubation procedure, an expected average of 15 minutes
measure: Time to successful orotracheal intubation
timeFrame: intubation procedure, an expected average of 15 minutes
Other outcomes:
measure: Cormack and Lehane grade
timeFrame: intubation procedure, an expected average of 15 minutes
measure: Percentage of glottic opening (POGO) score
timeFrame: intubation procedure, an expected average of 15 minutes
measure: Difficult Intubation
timeFrame: intubation procedure, an expected average of 15 minutes
measure: Resort to alternative intubation technique
timeFrame: intubation procedure, an expected average of 15 minutes
measure: Frequency of occurence of unexpected events
timeFrame: Discharge from Intensive Care unit, an expected average of 7 days
measure: Mechanical ventilation duration
timeFrame: Time from extubation, an expected average of 6 days
measure: Intensive Care Unit length of stay
timeFrame: Discharge from Intensive Care unit, an expected average of 7 days
measure: Hospital length of stay
timeFrame: Discharge from hospital, an expected average of 14 days
measure: Intensive Care Unit Mortality
timeFrame: Discharge from Intensive Care unit, an expected average of 7 days
measure: Mortality at day 28
timeFrame: Day 28
Locations:
city: Colombes
country: France
facility: CHU Louis Mourier
city: La Roche Sur Yon
country: France
facility: CHD Vendee
city: Orleans
country: France
facility: CHU Orleans
city: Paris
country: France
facility: CHU Saint Louis
city: Paris
country: France
facility: CHU Paris Cochin
city: Strasbourg
country: France
facility: CHU Strasbourg Nouvel Hôpital Civil
city: Tours
country: France
facility: CHU Tours
Study officials:
affiliation: CHD Vendee
name: Jean Baptiste Lascarrou, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bailly A, Lascarrou JB, Le Thuaut A, Boisrame-Helms J, Kamel T, Mercier E, Ricard JD, Lemiale V, Champigneulle B, Reignier J; Clinical Research in Intensive Care and Sepsis Group. McGRATH MAC videolaryngoscope versus Macintosh laryngoscope for orotracheal intubation in intensive care patients: the randomised multicentre MACMAN trial study protocol. BMJ Open. 2015 Dec 23;5(12):e009855. doi: 10.1136/bmjopen-2015-009855.
citation: Lascarrou JB, Boisrame-Helms J, Bailly A, Le Thuaut A, Kamel T, Mercier E, Ricard JD, Lemiale V, Colin G, Mira JP, Meziani F, Messika J, Dequin PF, Boulain T, Azoulay E, Champigneulle B, Reignier J; Clinical Research in Intensive Care and Sepsis (CRICS) Group. Video Laryngoscopy vs Direct Laryngoscopy on Successful First-Pass Orotracheal Intubation Among ICU Patients: A Randomized Clinical Trial. JAMA. 2017 Feb 7;317(5):483-493. doi: 10.1001/jama.2016.20603.