Clinical trial NCT02926144: Does McGRATH® MAC Videolaryngoscope Decrease the Number of People Required to Perform Intubation During Anesthesia ?
Official title: Can the Use of the McGRATH® MAC Videolaryngoscope Decrease the Number of People Required for Tracheal Intubation in a Population of Patients Without Predicted Difficult Intubation?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Keywords: Intratracheal intubation
videolaryngoscope
McGrath MAC
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2016-10-06
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The main objective of this study is to compare the proportion of tracheal intubations for which more than one person is necessary when using the McGRATH® MAC videolaryngoscope.

Detailed description: Videolaryngoscopes, such as McGRATH® MAC videolaryngoscope, are used to facilitate tracheal intubations. This study is designed to evaluate the proportion of cases requiring more than one member of the anesthesiology team when the video feature of McGRATH® MAC is available during laryngoscopy in a population of patients without a predicted difficult intubation (Arne's score \<11).

General anesthesia from induction until tracheal intubation is recorded on a video for further analysis. Analysis includes characteristics of intubation, patient's monitoring and cooperation between anesthesiologists in two groups. In the control group, the screen of the McGRATH® MAC videolaryngoscope is hidden. In the experimental group, the McGRATH® MAC videolaryngoscope is used with its video feature.

Eligibility criteria: Inclusion Criteria:

* Aged 18 years old minimum
* Requiring general anesthesia and orotracheal intubation with a single lumen tube
* Having signed an inform consent form
* Having a telephone and agreeing to communicate their phone number
* Benefiting from a social insurance scheme or beneficiary

Exclusion Criteria:

* Pregnant or breast-feeding women
* Patients taken care in ambulatory surgery who could not be contacted within 24 hours following surgery
* Patients having a predicted difficult intubation (Arné's score ≥ 11) or predicted difficult mask ventilation
* patients requiring a rapid-sequence intubation
* patients for whom general anesthesia using sufentanil, propofol, atracurium or rocuronium is not suitable.

Primary outcomes:
measure: Number of people needed for tracheal intubation when the video feature of McGRATH® MAC videolaryngoscope is available
timeFrame: 30 minutes
Secondary outcomes:
measure: Cooperation between members of the anesthesiology team during intubation
timeFrame: 30 minutes
measure: Intubation difficulty Scale (IDS)
timeFrame: 30 minutes
measure: Number of hands necessary for tracheal intubation
timeFrame: 30 minutes
measure: Time to intubate
timeFrame: 30 minutes
measure: Esophageal intubation
timeFrame: 30 minutes
measure: Intubation failure
timeFrame: 30 minutes
measure: Arterial desaturation
timeFrame: 30 minutes maximum
measure: Perception of intubation difficulty by the operator
timeFrame: 30 minutes
measure: Impact of videolaryngoscopy on hemodynamic variables
timeFrame: 30 minutes
measure: Evaluation of usual complications after tracheal intubation
timeFrame: 24 hours
Other outcomes:
Locations:
city: Levallois-Perret
country: France
facility: Institut Hospitalier Franco Britannique
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild
city: Soyaux
country: France
facility: Centre Clinical
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
affiliation: Hopital Foch
name: Olivier Belze, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Belze O, Coppere Z, Ouattara J, Thion LA, Paqueron X, Devys JM, Ma S, Kennel T, Fischler M, Le Guen M. Influence of videolaryngoscopy using McGrath Mac on the need for a helper to perform intubation during general anaesthesia: a multicentre randomised video-no-video trial. BMJ Open. 2022 Jan 3;12(1):e049275. doi: 10.1136/bmjopen-2021-049275.