AnesthesiaHELP-VDLNCT03987009
Do the Head-elevated Position and the Use of a Videolaryngoscope Facilitate Orotracheal Intubation in a Patient Population Without Predictable Difficulty of Intubation
A study testing Without RAMP and without video, With RAMP and with video and Without RAMP and with video in people with Anesthesia, run by Hopital Foch at 5 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Without RAMP and without video, With RAMP and with video and Without RAMP and with video
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 5 sitesFrance
- Study dates
- 31 Jul 2019to 11 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Groupe Hospitalier Diaconesses Croix Saint Simon
Paris, 75012
Hôpital Saint-Joseph
Paris, 75014
Institut Mutualiste Montsouris
Paris, 75014
Fondation Ophtalmologique Adolphe de Rothschild
Paris, 75019
Hôpital Foch
Suresnes, 92150
About this study
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.
Read the 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
- Being tested
- Without RAMP and without video, With RAMP and with video, Without RAMP and with video, With RAMP and without video
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Without RAMP and without videoDevice
Intubation with video-laryngoscope McGrath without use of the video feature and patient positioning without RAMP device
With RAMP and with videoDevice
Intubation with video-laryngoscope McGrath with use of the video feature and patient positioning with RAMP device
Without RAMP and with videoDevice
Intubation with video-laryngoscope McGrath with use of the video feature and patient positioning without RAMP device
With RAMP and without videoDevice
Intubation with video-laryngoscope McGrath without use of the video feature and patient positioning with RAMP device
| Study group | Role | What they receive |
|---|---|---|
| Without RAMP and without video | Experimental | Sniffing position and a standard Macintosh laryngoscope Receives: Device: Without RAMP and without video |
| With RAMP and with video | Experimental | Ramped position and a McGrath Mac videolaryngoscope Receives: Device: With RAMP and with video |
| Without RAMP and with video | Experimental | Sniffing position and a McGrath Mac videolaryngoscope Receives: Device: Without RAMP and with video |
| With RAMP and without video | Experimental | Ramped position and a standard Macintosh laryngoscope Receives: Device: With RAMP and without video |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 minutes
Secondary outcomes (14)
Time to perform the intubation
Based on the video recording: from the passage the incisors to the third capnogram
Measured: 30 minutes
First intubation succes rate
Defined by repositioning of the videolaryngoscope blade in the patient's mouth
Measured: 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)
Measured: 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)
Measured: 30 minutes
Assessment of quality of intubation with use of alternative techniques
Determined a posteriori from the video recording analysis
Measured: 30 minutes
Occurrence of esophageal intubation
Reported in real time by the operator during the video / audio recording
Measured: 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.
Measured: 30 minutes
Incidence of arterial oxygen desaturation (SpO2 < 92%)
Valued in real time and reported by the operator during the video / audio recording.
Measured: 30 minutes
Perception of difficulty in intubation
Evaluation in real time based on a scale betwwen zero ( no difficulty) to ten (extremely difficult)
Measured: 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)
Measured: 30 minutes
Evolution of Blood pressure
Blood pressure is monitored before the induction, before and after intubation.
Measured: 30 minutes
Evolution of Heart beat
Heart beat is monitored before the induction, before and after intubation.
Measured: 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
Measured: 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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start31 Jul 2019
- Primary completion11 Nov 2023
- Study completion11 Nov 2023
Why it stopped: Discontinuation of DM production by the manufacturer leading to recruitment difficulties in the centers.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Morgan Le Guen, MD, Principal investigator, Hôpital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03987009
- Sponsor's protocol ID
- 2017011F
- Acronym
- HELP-VDL
- Status last verified
- Feb 2025
- First submitted
- 7 Jun 2019
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available in the Dryad repository.
Publications
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.
PubMed 32641332
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03987009
- Acronym / sponsor ID
- HELP-VDL / 2017011F
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Discontinuation of DM production by the manufacturer leading to recruitment difficulties in the centers.
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 31 Jul 2019 (actual)
- Primary completion
- 11 Nov 2023 (actual)
- Study completion
- 11 Nov 2023 (actual)
- First posted
- 14 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Without RAMP and without video | Experimental | Device: Without RAMP and without videoSniffing position and a standard Macintosh laryngoscope |
| With RAMP and with video | Experimental | Device: With RAMP and with videoRamped position and a McGrath Mac videolaryngoscope |
| Without RAMP and with video | Experimental | Device: Without RAMP and with videoSniffing position and a McGrath Mac videolaryngoscope |
| With RAMP and without video | Experimental | Device: With RAMP and without videoRamped position and a standard Macintosh laryngoscope |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Without RAMP and without videoIntubation with video-laryngoscope McGrath without use of the video feature and patient positioning without RAMP device | Device | Without RAMP and without video |
| With RAMP and with videoIntubation with video-laryngoscope McGrath with use of the video feature and patient positioning with RAMP device | Device | With RAMP and with video |
| Without RAMP and with videoIntubation with video-laryngoscope McGrath with use of the video feature and patient positioning without RAMP device | Device | Without RAMP and with video |
| With RAMP and without videoIntubation with video-laryngoscope McGrath without use of the video feature and patient positioning with RAMP device | Device | With RAMP and without video |
Primary outcome
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
14 secondary outcomes
Time to perform the intubation
Time frame: 30 minutes
First intubation succes rate
Time frame: 30 minutes
Assessment of the Quality of visualization of the glottis
Time frame: 30 minutes
Assessment of the Percentage of the opening of the glottic orifice
Time frame: 30 minutes
Assessment of quality of intubation with use of alternative techniques
Time frame: 30 minutes
Occurrence of esophageal intubation
Time frame: 30 minutes
Number of tracheal intubation failure
Time frame: 30 minutes
Incidence of arterial oxygen desaturation (SpO2 < 92%)
Time frame: 30 minutes
Perception of difficulty in intubation
Time frame: 30 minutes
Cooperation of the various members of the anesthesia team
Time frame: 30 minutes
Evolution of Blood pressure
Time frame: 30 minutes
Evolution of Heart beat
Time frame: 30 minutes
Evaluation of frequency of intubation complications
Time frame: 24 hours
Evaluation of severity of intubation complications
Time frame: 24 hours
Results and safety
The study was stopped early (reason given: Discontinuation of DM production by the manufacturer leading to recruitment difficulties in the centers.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Derived from this study: PubMed 32641332Le 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.
- Individual participant dataSharing planned: Yes. Data will be available in the Dryad repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morgan Le Guen, MD principal investigator
Hôpital Foch
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Without RAMP and without video, With RAMP and with video and Without RAMP and with video in people with Anesthesia, run by Hopital Foch at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Discontinuation of DM production by the manufacturer leading to recruitment difficulties in the centers.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03987009, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.