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

Anesthesia Clinical Trial

— HELP-VDL  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03987009
• Other study ID #: 2017011F
• Status: Recruiting
• Phase: N/A
• Start date: July 31, 2019
• Est. completion date: June 2024

Study information

• Verified date: June 2024
• Source: Hopital Foch
• Contact: Elisabeth Hullier-Ammar
• Phone: +33 1 46 25 11 75
• Email: drci-promotion[@]hopital-foch.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

Device:
• Without RAMP and without video
Intubation with video-laryngoscope McGrath without use of the video feature and patient positioning without RAMP device
• With RAMP and with video
Intubation with video-laryngoscope McGrath with use of the video feature and patient positioning with RAMP device
• Without RAMP and with video
Intubation with video-laryngoscope McGrath with use of the video feature and patient positioning without RAMP device
• With RAMP and without video
Intubation with video-laryngoscope McGrath without use of the video feature and patient positioning with RAMP device

Locations

Country	Name	City	State
France	Fondation Ophtalmologique Adolphe de Rothschild	Paris
France	Groupe Hospitalier Diaconesses Croix Saint Simon	Paris
France	Hôpital Saint-Joseph	Paris
France	Institut Mutualiste Montsouris	Paris
France	Hôpital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to perform the intubation	Based on the video recording: from the passage the incisors to the third capnogram	30 minutes
Secondary	First intubation succes rate	Defined by repositioning of the videolaryngoscope blade in the patient's mouth	30 minutes
Secondary	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
Secondary	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
Secondary	Assessment of quality of intubation with use of alternative techniques	Determined a posteriori from the video recording analysis	30 minutes
Secondary	Occurrence of esophageal intubation	Reported in real time by the operator during the video / audio recording	30 minutes
Secondary	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
Secondary	Incidence of arterial oxygen desaturation (SpO2 < 92%)	Valued in real time and reported by the operator during the video / audio recording.	30 minutes
Secondary	Perception of difficulty in intubation	Evaluation in real time based on a scale betwwen zero ( no difficulty) to ten (extremely difficult)	30 minutes
Secondary	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
Secondary	Evolution of Blood pressure	Blood pressure is monitored before the induction, before and after intubation.	30 minutes
Secondary	Evolution of Heart beat	Heart beat is monitored before the induction, before and after intubation.	30 minutes
Secondary	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
Secondary	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