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

NCT02413723 — Not applicable, Completed, 371 participants, Centre Hospitalier Departemental Vendee

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RegistryNCT02413723, acronym MACMAN
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, supportive care
Enrollment371 (Actual)
SponsorCentre Hospitalier Departemental Vendee (Other); collaborators: Nantes University Hospital
ConditionsIntratracheal Intubation in Critical Care
InterventionsVideolaryngoscope, Standard laryngoscope (Device)
Datesstart 2015-05-01, primary completion 2015-11-01, completion 2016-02-01, first posted 2015-04-10, last updated 2025-11-17
Locations7 sites in France

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Videolaryngoscope McGrath MacActive comparatorDevice: VideolaryngoscopeMcGrath Mac videolaryngoscope will be used for laryngoscopy for patient's intubation
Standard laryngoscopePlacebo comparatorDevice: Standard laryngoscopeMacintosh laryngoscope will be used for laryngoscopy for patient's intubation
  • Videolaryngoscope (Device), also known as Mc Grath videolaryngoscope: McGrath Mac videolaryngoscope will be use for first attempt of intratracheal intubation.
  • Standard laryngoscope (Device), also known as Macintosh laryngoscope: Macintosh laryngoscope will be use for first attempt of intratracheal intubation.

+Outcome measures

Primary outcomes

  • 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 outcomes

  • 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)

Other outcomes

  • Cormack and Lehane grade [intubation procedure, an expected average of 15 minutes]
  • Percentage of glottic opening (POGO) score [intubation procedure, an expected average of 15 minutes]
  • Difficult Intubation [intubation procedure, an expected average of 15 minutes]
  • Resort to alternative intubation technique [intubation procedure, an expected average of 15 minutes]
  • Frequency of occurence of unexpected events [Discharge from Intensive Care unit, an expected average of 7 days]
  • Mechanical ventilation duration [Time from extubation, an expected average of 6 days]
  • Intensive Care Unit length of stay [Discharge from Intensive Care unit, an expected average of 7 days]
  • Hospital length of stay [Discharge from hospital, an expected average of 14 days]
  • Intensive Care Unit Mortality [Discharge from Intensive Care unit, an expected average of 7 days]
  • Mortality at day 28 [Day 28]

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (7)

FacilityCityCountryStatus
CHU Louis MourierColombesFrance
CHD VendeeLa Roche-sur-YonFrance
CHU OrleansOrléansFrance
CHU Saint LouisParisFrance
CHU Paris CochinParisFrance
CHU Strasbourg Nouvel Hôpital CivilStrasbourgFrance
CHU ToursToursFrance

+Publications

  • Lascarrou JB, Le Thuaut A, Reignier J. Intubation With Video Laryngoscopy vs Direct Laryngoscopy-Reply. JAMA. 2017 May 23;317(20):2131-2132. doi: 10.1001/jama.2017.4486. No abstract available. PMID 28535229
  • 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. PMID 26700287
  • Results publication: 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. PMID 28118659

+Investigators

My Notes