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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 (HELP-VDL)

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ClinicalTrials.gov Identifier: NCT03987009
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : May 6, 2020
Sponsor:
Information provided by (Responsible Party):
Hopital Foch

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.


Condition or disease Intervention/treatment Phase
Anesthesia Device: Without RAMP and without video Device: With RAMP and with video Device: Without RAMP and with video Device: With RAMP and without video Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
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
Actual Study Start Date : July 31, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

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




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


Secondary Outcome Measures :
  1. Time to perform the intubation [ Time Frame: 30 minutes ]
    Based on the video recording: from the passage the incisors to the first capnogram

  2. First intubation succes rate [ Time Frame: 30 minutes ]
    Defined by repositioning of the videolaryngoscope blade in the patient's mouth

  3. Assessment of the Quality of visualization of the glottis [ Time Frame: 30 minutes ]
    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)

  4. Assessment of the Percentage of the opening of the glottic orifice [ Time Frame: 30 minutes ]
    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)

  5. Assessment of quality of intubation with use of alternative techniques [ Time Frame: 30 minutes ]
    Determined a posteriori from the video recording analysis

  6. Occurrence of esophageal intubation [ Time Frame: 30 minutes ]
    Reported in real time by the operator during the video / audio recording

  7. Number of tracheal intubation failure [ Time Frame: 30 minutes ]
    Number of tracheal intubation failure reported by the operator during the video / audio recording. Can be determined a posteriori from the video / audio recording.

  8. Incidence of arterial oxygen desaturation (SpO2 < 92%) [ Time Frame: 30 minutes ]
    Valued in real time and reported by the operator during the video / audio recording.

  9. Perception of difficulty in intubation [ Time Frame: 30 minutes ]
    Evaluation in real time based on a scale betwwen zero ( no difficulty) to ten (extremely difficult)

  10. Cooperation of the various members of the anesthesia team [ Time Frame: 30 minutes ]
    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)

  11. Evolution of Blood pressure [ Time Frame: 30 minutes ]
    Blood pressure is monitored before the induction, before and after intubation.

  12. Evolution of Heart beat [ Time Frame: 30 minutes ]
    Heart beat is monitored before the induction, before and after intubation.

  13. Evaluation of frequency of intubation complications [ Time Frame: 24 hours ]
    Number of events of Sore throat and voice change evaluated during postoperative visit on day 1 of the surgery

  14. Evaluation of severity of intubation complications [ Time Frame: 24 hours ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987009


Contacts
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Contact: Elisabeth Hullier-Ammar +33 1 46 25 11 75 drci-promotion@hopital-foch.com

Locations
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France
Groupe Hospitalier Diaconesses Croix Saint Simon Not yet recruiting
Paris, France, 75012
Contact: Jean-Michel Devys, MD         
Principal Investigator: Jean-Michel Devys, MD         
Hôpital Saint-Joseph Not yet recruiting
Paris, France, 75014
Contact: Pascal Alfonsi, MD         
Principal Investigator: Pascal Alfonsi, MD         
Institut Mutualiste Montsouris Not yet recruiting
Paris, France, 75014
Contact: Marc Beaussier, MD         
Principal Investigator: Marc Beaussier, MD         
Fondation Ophtalmologique Adolphe de Rothschild Not yet recruiting
Paris, France, 75019
Contact: Jean-Michel Devys, MD         
Principal Investigator: Jean-Michel Devys, MD         
Hôpital Foch Recruiting
Suresnes, France, 92150
Contact: Marc Fischler, MD, PhD    +33 1 46 25 24 42    m.fischler@hopital-foch.org   
Principal Investigator: Morgan Le Guen, MD         
Sponsors and Collaborators
Hopital Foch
Investigators
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Principal Investigator: Morgan Le Guen, MD Hôpital Foch
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT03987009    
Other Study ID Numbers: 2017011F
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be available in the Dryad repository.
Supporting Materials: Analytic Code
Time Frame: After publication in a peer-review journal. No limit in time
Access Criteria: No criteria
URL: https://datadryad.org/stash

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No