Clinical trial NCT03987009: Do the Head-elevated Position and the Use of a Videolaryngoscope Facilitate Orotracheal Intubation in a Patient Population Without Predictable Difficulty of Intubation
Official title: Do the Head-elevated Position and the Use of a Videolaryngoscope Facilitate Orotracheal Intubation in a Patient Population Without Predictable Difficulty of Intubation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anesthesia
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2019-06-14
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The main hypothesis of this study is that there is a synergy between the use of the HELP position and the use of a McGrath® Mac videolaryngoscope to facilitate tracheal intubation during anesthesia.

The HELP position is the patient positioning on the AirPal RAMP, the two cushions inflated, bringing the external auditory canal to the same level as the sus-sternal notch.

Detailed description: Airway management remains an important determinant of morbidity and mortality in anesthesia, despite progress in recognizing factors of difficult mask ventilation and intubation. Many recommendations have been published regarding the practice of intubation in anesthesia. Our study focuses on two topics which remain under discussion: the position of the patient's head and the use of a videolaryngoscope.

As to patient's head position, most anesthesiologists place the patient in the sniffing position (supine torso with neck flexed forward, and head extended), a position denominated "sniffing"by analogy to that adopted to smell a perfume. However, Adnet et al. questioned this position based on magnetic resonance imaging of eight healthy young volunteers positioned either with their heads in a neutral position or in extension, or with their heads and necks on a pillow. They showed that the sniffing position does not allow the alignment of the three important axes (mouth, pharynx and larynx) in awake patients with normal airway anatomy \[1\]. The "Head Elevated Laryngoscopic position" (HELP), with a raise of the head and neck so that "An imaginary horizontal line should connect the patient's sternal notch with the external auditory meatus" \[2\] facilitates the alignment of the pharyngeal, laryngeal, and oral axes of the airway during difficult laryngoscopy \[3\].

As to videolaryngoscopy, there is no doubt that it is a major advance in airway management. A recent Cochrane Systematic Review concluded that videolaryngoscopy increased easy laryngeal views and reduced difficult views and intubation difficulty \[4\]. However, its place is still debated: first line or rescue in case of suspected difficult airway. Its systematic use means discarding the standard Macintosh laryngoscope \[5\] which is not supported by clinical studies, in particular those of Wallace et al. \[6\] and of Thion et al. \[7\].

In the present randomized study we will study a combination of two factors in tracheal intubation on patients without suspected airways abnormalities: position (sniffing or HELP) and a McGrath laryngoscope (with or without video). This leads to four groups, A: sniffing position plus McGrath Mac videolaryngoscope with its screen deactivated so as to mimic a plain laryngoscope (R-V-), B: HELP plus McGrath Mac videolaryngoscope with a deactivated video screen (R+V-), C: sniffing position plus a McGrath Mac videolaryngoscope with an activated video screen (R-V+), D: HELP plus a McGrath Mac videolaryngoscope with it video screen activated (R+V+). This protocol allows using the same type of laryngoscope in all cases.

Eligibility criteria: Inclusion Criteria:

* Aged 18 - 89 years old
* Scheduled for elective surgical procedures
* Requiring oro-tracheal intubation for general anesthesia
* Having a telephone and agreeing to communicate their phone number in case of ambulatory surgery
* Having signed an informed consent form
* Benefiting from a social insurance

Exclusion Criteria:

* Pregnant or breast-feeding women
* Patients with an anticipated difficult mask ventilation or an anticipated difficult intubation (Arné's score ≥ 11)
* Patients scheduled for a surgical procedure involving the mouth or the upper airway
* Patients requiring a rapid induction sequence, the use of a double-lumen tube
* Patients having a contra-indication to one of the drug administered by the protocol

Primary outcomes:
measure: Proportion of oro-tracheal intubations for which it is necessary to use the assistance of a third party required by the operator
timeFrame: 30 minutes
Secondary outcomes:
measure: Time to perform the intubation
timeFrame: 30 minutes
measure: First intubation succes rate
timeFrame: 30 minutes
measure: Assessment of the Quality of visualization of the glottis
timeFrame: 30 minutes
measure: Assessment of the Percentage of the opening of the glottic orifice
timeFrame: 30 minutes
measure: Assessment of quality of intubation with use of alternative techniques
timeFrame: 30 minutes
measure: Occurrence of esophageal intubation
timeFrame: 30 minutes
measure: Number of tracheal intubation failure
timeFrame: 30 minutes
measure: Incidence of arterial oxygen desaturation (SpO2 < 92%)
timeFrame: 30 minutes
measure: Perception of difficulty in intubation
timeFrame: 30 minutes
measure: Cooperation of the various members of the anesthesia team
timeFrame: 30 minutes
measure: Evolution of Blood pressure
timeFrame: 30 minutes
measure: Evolution of Heart beat
timeFrame: 30 minutes
measure: Evaluation of frequency of intubation complications
timeFrame: 24 hours
measure: Evaluation of severity of intubation complications
timeFrame: 24 hours
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Diaconesses Croix Saint Simon
city: Paris
country: France
facility: Hôpital Saint-Joseph
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild
city: Suresnes
country: France
facility: Hôpital Foch
Study officials:
affiliation: Hôpital Foch
name: Morgan Le Guen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Le Guen M, Coppere Z, Dufour G, Ouattara J, Trichereau J, Fischler M. HELP-VDL: study protocol for a multicentre, open, randomised, controlled clinical trial comparing the use of the head-elevated laryngoscopy position and the use of a videolaryngoscope to facilitate orotracheal intubation in a patient population without predictable difficulty of intubation. BMJ Open. 2020 Jul 8;10(7):e036570. doi: 10.1136/bmjopen-2019-036570.