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

NCT ID: NCT03987009

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-31
• Study Completion Date: 2023-11-11

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.

Conditions

Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Without RAMP and without video

Sniffing position and a standard Macintosh laryngoscope

Group Type: EXPERIMENTAL

Without RAMP and without video

Intervention Type: DEVICE

Intubation with video-laryngoscope McGrath without use of the video feature and patient positioning without RAMP device

With RAMP and with video

Ramped position and a McGrath Mac videolaryngoscope

Group Type: EXPERIMENTAL

With RAMP and with video

Intervention Type: DEVICE

Intubation with video-laryngoscope McGrath with use of the video feature and patient positioning with RAMP device

Without RAMP and with video

Sniffing position and a McGrath Mac videolaryngoscope

Group Type: EXPERIMENTAL

Without RAMP and with video

Intervention Type: DEVICE

Intubation with video-laryngoscope McGrath with use of the video feature and patient positioning without RAMP device

With RAMP and without video

Ramped position and a standard Macintosh laryngoscope

Group Type: EXPERIMENTAL

With RAMP and without video

Intervention Type: DEVICE

Intubation with video-laryngoscope McGrath without use of the video feature and patient positioning with RAMP device

Interventions

Without RAMP and without video

Intubation with video-laryngoscope McGrath without use of the video feature and patient positioning without RAMP device

Intervention Type: DEVICE

With RAMP and with video

Intubation with video-laryngoscope McGrath with use of the video feature and patient positioning with RAMP device

Intervention Type: DEVICE

Without RAMP and with video

Intubation with video-laryngoscope McGrath with use of the video feature and patient positioning without RAMP device

Intervention Type: DEVICE

With RAMP and without video

Intubation with video-laryngoscope McGrath without use of the video feature and patient positioning with RAMP device

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hopital Foch

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Morgan Le Guen, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Foch

Locations

Groupe Hospitalier Diaconesses Croix Saint Simon

Paris, , France

Hôpital Saint-Joseph

Paris, , France

Institut Mutualiste Montsouris

Paris, , France

Fondation Ophtalmologique Adolphe de Rothschild

Paris, , France

Hôpital Foch

Suresnes, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 32641332 (View on PubMed)

Other Identifiers

2017011F

Identifier Type: -

Identifier Source: org_study_id