Do the Head-elevated Position and the Use of a Videolaryngoscope Facilitate Orotracheal Intubation in a Patient Population Without Predictable Difficulty of Intubation (HELP-VDL)

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.

Study Overview

• Status: Terminated
• Conditions: Anesthesia
• Intervention / Treatment: Device: Without RAMP and without video; Device: With RAMP and with video; Device: Without RAMP and with video; Device: With RAMP and without video

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.

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Institut Mutualiste Montsouris
  • Paris, France, 75019
    • Fondation Ophtalmologique Adolphe de Rothschild
  • Paris, France, 75014
    • Hôpital Saint-Joseph
  • Paris, France, 75012
    • Groupe Hospitalier Diaconesses Croix Saint Simon
  • Suresnes, France, 92150
    • Hôpital Foch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Without RAMP and without video; Sniffing position and a standard Macintosh laryngoscope	Device: Without RAMP and without video; Intubation with video-laryngoscope McGrath without use of the video feature and patient positioning without RAMP device
Experimental: With RAMP and with video; Ramped position and a McGrath Mac videolaryngoscope	Device: With RAMP and with video; Intubation with video-laryngoscope McGrath with use of the video feature and patient positioning with RAMP device
Experimental: Without RAMP and with video; Sniffing position and a McGrath Mac videolaryngoscope	Device: Without RAMP and with video; Intubation with video-laryngoscope McGrath with use of the video feature and patient positioning without RAMP device
Experimental: With RAMP and without video; Ramped position and a standard Macintosh laryngoscope	Device: With RAMP and without video; Intubation with video-laryngoscope McGrath without use of the video feature and patient positioning with RAMP device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of oro-tracheal intubations for which it is necessary to use the assistance of a third party required by the operator	Intubation is video and audio recorded. The number of people nedeed is determined from the audio/video recording a posteriori by two independent evaluators	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to perform the intubation	Based on the video recording: from the passage the incisors to the third capnogram	30 minutes
First intubation succes rate	Defined by repositioning of the videolaryngoscope blade in the patient's mouth	30 minutes
Assessment of the Quality of visualization of the glottis	It is appreciated in real time by score of Cormak and Lehane modified by Yentis : from Grade 1 (glottis seen in totality) to Grade 4 (glottis hidden by epiglottis and tongue)	30 minutes
Assessment of the Percentage of the opening of the glottic orifice	It is appreciated in real time POGO (Percentage of Opening of the Glottic orifice) score : from 0% (opening not visible) to 100% (all of the opening is visible)	30 minutes
Assessment of quality of intubation with use of alternative techniques	Determined a posteriori from the video recording analysis	30 minutes
Occurrence of esophageal intubation	Reported in real time by the operator during the video / audio recording	30 minutes
Number of tracheal intubation failure	Number of tracheal intubation failure reported by the operator during the video / audio recording. Can be determined a posteriori from the video / audio recording.	30 minutes
Incidence of arterial oxygen desaturation (SpO2 < 92%)	Valued in real time and reported by the operator during the video / audio recording.	30 minutes
Perception of difficulty in intubation	Evaluation in real time based on a scale betwwen zero ( no difficulty) to ten (extremely difficult)	30 minutes
Cooperation of the various members of the anesthesia team	Determined from the video / audio recording using Kraus Scale to evaluate cooperation and non-cooperation behaviors within the team. Positive rating: scale from 0 (never reported by the obsever) to 4 (obvious to the obsever). Negative rating: scale from 0 (nerver reported by the observer) to 4 (obvious most of the time for the observer)	30 minutes
Evolution of Blood pressure	Blood pressure is monitored before the induction, before and after intubation.	30 minutes
Evolution of Heart beat	Heart beat is monitored before the induction, before and after intubation.	30 minutes
Evaluation of frequency of intubation complications	Number of events of Sore throat and voice change evaluated during postoperative visit on day 1 of the surgery	24 hours
Evaluation of severity of intubation complications	Severity is evaluated during postoperative visit on day 1 of the surgery with 2 questions to the patient about his/her sore throat and voice change	24 hours

Collaborators and Investigators

• Sponsor: Hopital Foch
• Investigators: Principal Investigator: Morgan Le Guen, MD, Hôpital Foch

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2019
• Primary Completion (Actual): November 11, 2023
• Study Completion (Actual): November 11, 2023

Study Registration Dates

• First Submitted: June 7, 2019
• First Submitted That Met QC Criteria: June 13, 2019
• First Posted (Actual): June 14, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 10, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2017011F

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be available in the Dryad repository.
• IPD Sharing Time Frame: After publication in a peer-review journal. No limit in time
• IPD Sharing Access Criteria: No criteria
• IPD Sharing Supporting Information Type: ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No