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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03987009
Acronym
HELP-VDL
Enrollment
121
Registered
2019-06-14
Start date
2019-07-31
Completion date
2023-11-11
Last updated
2025-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

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 sniffingby 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.

Interventions

DEVICEWithout RAMP and without video

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

DEVICEWith RAMP and with video

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

DEVICEWithout RAMP and with video

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

DEVICEWith RAMP and without video

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

Sponsors

Hopital Foch
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of oro-tracheal intubations for which it is necessary to use the assistance of a third party required by the operator30 minutesIntubation is video and audio recorded. The number of people nedeed is determined from the audio/video recording a posteriori by two independent evaluators

Secondary

MeasureTime frameDescription
First intubation succes rate30 minutesDefined by repositioning of the videolaryngoscope blade in the patient's mouth
Assessment of the Quality of visualization of the glottis30 minutesIt 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)
Assessment of the Percentage of the opening of the glottic orifice30 minutesIt 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)
Assessment of quality of intubation with use of alternative techniques30 minutesDetermined a posteriori from the video recording analysis
Occurrence of esophageal intubation30 minutesReported in real time by the operator during the video / audio recording
Number of tracheal intubation failure30 minutesNumber of tracheal intubation failure reported by the operator during the video / audio recording. Can be determined a posteriori from the video / audio recording.
Time to perform the intubation30 minutesBased on the video recording: from the passage the incisors to the third capnogram
Perception of difficulty in intubation30 minutesEvaluation in real time based on a scale betwwen zero ( no difficulty) to ten (extremely difficult)
Cooperation of the various members of the anesthesia team30 minutesDetermined 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)
Evolution of Blood pressure30 minutesBlood pressure is monitored before the induction, before and after intubation.
Evolution of Heart beat30 minutesHeart beat is monitored before the induction, before and after intubation.
Evaluation of frequency of intubation complications24 hoursNumber of events of Sore throat and voice change evaluated during postoperative visit on day 1 of the surgery
Evaluation of severity of intubation complications24 hoursSeverity 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
Incidence of arterial oxygen desaturation (SpO2 < 92%)30 minutesValued in real time and reported by the operator during the video / audio recording.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026