An interventional study of Without RAMP and without video and With RAMP and with video in Anesthesia, sponsored by Hopital Foch. Terminated at 5 sites in France. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2025-02-12.
Sponsored by Hopital Foch · Not applicable, Interventional, and Other
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.
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.
Hopital Foch is the lead sponsor of 215 studies on the registry; 21 are open to participants now.
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Exclusion Criteria:
Sniffing position and a standard Macintosh laryngoscope
Device: Without RAMP and without video
Ramped position and a McGrath Mac videolaryngoscope
Device: With RAMP and with video
Sniffing position and a McGrath Mac videolaryngoscope
Device: Without RAMP and with 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 without RAMP device
Intubation with video-laryngoscope McGrath with use of the video feature and patient positioning with RAMP device
Intubation with video-laryngoscope McGrath with use of the video feature and patient positioning without RAMP device
Intubation with video-laryngoscope McGrath without use of the video feature and patient positioning with RAMP device
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
Time frame: 30 minutes
Time to perform the intubation
Based on the video recording: from the passage the incisors to the third capnogram
Time frame: 30 minutes
First intubation succes rate
Defined by repositioning of the videolaryngoscope blade in the patient's mouth
Time frame: 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)
Time frame: 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)
Time frame: 30 minutes
Assessment of quality of intubation with use of alternative techniques
Determined a posteriori from the video recording analysis
Time frame: 30 minutes
Occurrence of esophageal intubation
Reported in real time by the operator during the video / audio recording
Time frame: 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.
Time frame: 30 minutes
Incidence of arterial oxygen desaturation (SpO2 < 92%)
Valued in real time and reported by the operator during the video / audio recording.
Time frame: 30 minutes
Perception of difficulty in intubation
Evaluation in real time based on a scale betwwen zero ( no difficulty) to ten (extremely difficult)
Time frame: 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)
Time frame: 30 minutes
Evolution of Blood pressure
Blood pressure is monitored before the induction, before and after intubation.
Time frame: 30 minutes
Evolution of Heart beat
Heart beat is monitored before the induction, before and after intubation.
Time frame: 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
Time frame: 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
Time frame: 24 hours
Plan to share: Yes — Data will be available in the Dryad repository.
Supporting information: Analytic code
Time frame: After publication in a peer-review journal. No limit in time
Access criteria: No criteria
Data sharing details ↗ · datadryad.org
Ran from Jul 2019 to primary completion in Nov 2023, 51 months.
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This study is terminated, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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