ClinicalTrials.gg
CompletedNCT05671978Updated Jan 29, 2026

Head Elevated Position and Hyper-angulated Video-laryngoscope Guided Intubation

An interventional study of back-up head elevated position and neutral position in Intubation; Difficult or Failed, sponsored by Hallym University Kangnam Sacred Heart Hospital. Completed at 1 site in South Korea. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-29.

Sponsored by Hallym University Kangnam Sacred Heart Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
182
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Cervical immobilization with manual in-line stabilization (MILS) is recommended to prevent further neurologic injury during intubation in patients with known or suspected cervical spine injuries. However, MILS is associated with increased rates of failed tracheal intubation using direct laryngoscopy, because the restriction of neck flexion and head extension may prevent adequate alignment of the oral, pharyngeal, and tracheal axes, hence adversely affecting laryngeal visualization during direct laryngoscopy.

The GlideScope® (Verathon, Bothell, WA, USA) is a videolaryngoscope with an hyer-angulated blade (HA-VL), which is characterized by a sharper curvature than the Macintosh blade. The large curvature of the HA-VL allows seeing 'round the corner', which can provide indirect laryngeal visualization even with restricted neck movements . However, the HA-VL also prevents direct visualization of larynx, which make it difficult to guide the tracheal tube (TT) towards the glottis despite obtaining a good laryngeal view. Thus, the good view of the laryngeal inlet provided by videolaryngoscopes does not always lead to an easy or successful intubation. There are numerous reports in the literature of devices managing to achieve an improvement in view but still being unable to pass an TT to laryngeal inlet. Thus, the key to a successful tracheal intubation using HA-VL lies not in the laryngeal view obtained but in the ease of inserting the TT. Recent meta studies comparing alternative intubation devices with the standard Macintosh laryngoscope in subjects with cervical spine immobilization reported that GlideScope® was associated with improved glottis visualization but no statistically significant differences in intubation failure or time to intubation compared with direct laryngoscopy.

The sniffing position recommended for direct laryngoscopy has been reported to interfere with successful tracheal intubation with HA-VL because flexion of the neck narrows the angle between the sternum and the chin, making it more difficult to insert the HA-VL blade into mouth. In contrast, placing the patient in a 'neutral' or 'back-up head-elevated (BUHE)' position was not associated with a higher incidence of difficult laryngoscope with HA-VL. Given that the 'BUHE' position, when compared with the regular supine position, extend the safe apnoea time during direct laryngoscopy, this position seems better suited for HA-VL than neutral position. However, there is currently insufficient evidence to recommend a specific patient position for the use of HA-VL.

Previous studies using magnetic resonance imaging (MRI) suggests that head elevation until the external auditory meatus and sternal notch (AM-S) are in the horizonal plane leads to better anatomic alignment of the pharyngeal and laryngeal axes. Investigators therefore hypothesized that BUHE position (to align the AM-S in horizontal plane), compared with neutral position, would allow a relatively straight passage which makes it easier to guide the TT into the laryngeal inlet (facilitates insertion of TT into the laryngeal entrance) during HA-VL guided intubation. To compare the effect of the BUHE position and the neutral position on the ease of tracheal intubation using a HA-VL (GlideScope®), MILS was applied to patients without any known or suspected neck pathology as a way of simulating a difficult airway. The primary outcome was the tracheal intubation time with both positions. Secondary outcomes examined included rates of successful tracheal intubation and intubation success rate, number of intubation attempts, heart rate responses during intubation, and handling of the Glidesope VL after alignment of the EAM and sternal notch.

02

Conditions studied

  • Intubation; Difficult or Failed
03

In context

Lead sponsor

Hallym University Kangnam Sacred Heart Hospital is the lead sponsor of 34 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients of 1-2 who were scheduled for elective surgery under general anaesthesia requiring tracheal intubation.

Exclusion criteria

Exclusion Criteria:

  • if they required rapid sequence induction;
  • history of previous difficult direct laryngoscopy
  • unwilling to provide
  • uncontrolled hypertension
  • history of ischaemic heart disease without optimal control of symptoms
  • history of acute or recent stroke or myocardial infarction
  • cervical spine instability or cervical myelopathy
  • symptomatic asthma or reactive airway disease requiring daily pharmacological treatment for control of symptoms
  • history of gastric reflux.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
182 participants (actual)

Study arms

  • Placebo comparator
    neutral position

    intubation was performed in the neutral position

    Procedure: neutral position

  • Experimental
    back-up head elevated position

    he trachea was intubated in the back-up head elevated position

    Procedure: back-up head elevated position

Interventions

  • Procedureback-up head elevated position

    The patient was then placed in the back-up head elevated position to align the external auditory meatus and sternal notch, which was achieved by breaking the operating table

  • Procedureneutral position

    The patient was then placed in the netural position

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What researchers measure

Primary outcomes

  1. ease of tracheal intubation (easy/modified/unachievable)

    the need for optimization procedure to facilitate laryngeal visualization and tracheal intubation easy: no need for optimization procedure. modified: need for optimization procedure unachievable: unable to insert tracheal tube even after optimzation procedure

    Time frame: The time from the insertion of laryngoscope into oral cavity until tracheal intubation over 1minute period

Secondary outcomes

  1. intubation time

    time required for intubation

    Time frame: : The time from the insertion of laryngoscope into oral cavity until its removal over 1 minute period

  2. percentage of glottic opening (POGO) score (0-100%)

    percentage of glottic opening (0 - 100) 0%: visualization of none of the glottis 100%: visualization of the whole glottis

    Time frame: During laryngeal visualization by laryngoscope over 1 minute period

07

Study locations

1 site
  • Hallym University Kangnam Sacred Heart Hospital
    Seoul, South Korea
08

References and documents

Publications

  • Lee SH, Kim KM, Choi EM, Son JM, Park J, Jun JH. Effect of head-elevated versus neutral position on tracheal intubation using a hyper-angulated video laryngoscope under cervical spine immobilization: a randomised crossover trial. Anaesth Crit Care Pain Med. 2026 Jul;45(4):101720. doi: 10.1016/j.accpm.2025.101720. Epub 2025 Dec 3. PubMed 41349843 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2023 to primary completion in Jul 2023, 6 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 3, 2023
First posted
Jan 5, 2023
StartActual
Jan 16, 2023
Primary completionActual
Jul 31, 2023
CompletionActual
Jul 31, 2023
Last update
Jan 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05671978
Lead sponsor
Hallym University Kangnam Sacred Heart Hospital
Responsible party
Jun joohyun (Associate Professor, Hallym University Kangnam Sacred Heart Hospital) — Principal investigator
First posted
Jan 5, 2023
Start date
Jan 16, 2023
Primary completion
Jul 31, 2023
Completion
Jul 31, 2023
Last update
Jan 29, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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