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Intubation; Difficult or FailedNCT05671978

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

A study testing back-up head elevated position and neutral position in people with Intubation; Difficult or Failed, run by Hallym University Kangnam Sacred Heart Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Intubation; Difficult or Failed
What is being tested?
back-up head elevated position and neutral position
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
182 participants
Where
1 siteSouth Korea
Study dates
16 Jan 2023to 31 Jul 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 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • if they required rapid sequence induction;
  • history of previous difficult direct laryngoscopy
  • unwilling to provide informed consent
  • uncontrolled hypertension
  • history of ischaemic heart disease without optimal control of symptoms
  • history of acute or recent stroke or myocardial infarction
Show all 9Show fewer
  • cervical spine instability or cervical myelopathy
  • symptomatic asthma or reactive airway disease requiring daily pharmacological treatment for control of symptoms
  • history of gastric reflux.

Trial locations and contacts

1 site in 1 country.

South Korea1 site
  • Hallym University Kangnam Sacred Heart Hospital

    Seoul

Other trials in South Korea

About this study

Official title: Effect of Head Elevated Position on Ease of Tracheal Intubation Using Hyper-angulated Video-laryngoscope in Patients With Simulated Difficult Airway

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.

Read more

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.

Being tested
back-up head elevated position, neutral position

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • back-up head elevated positionProcedure or surgery

    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

  • neutral positionProcedure or surgery

    The patient was then placed in the netural position

Study groups in NCT05671978
Study groupRoleWhat they receive
neutral positionPlacebo comparatorintubation was performed in the neutral position
Receives: Procedure: neutral position
back-up head elevated positionExperimentalhe trachea was intubated in the back-up head elevated position
Receives: Procedure: back-up head elevated position

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (2)
  1. intubation time

    time required for intubation

    Measured: : 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

    Measured: During laryngeal visualization by laryngoscope over 1 minute period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2023
  2. Study start16 Jan 2023
  3. Primary completion31 Jul 2023
  4. Study completion31 Jul 2023

Resources

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
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
182 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05671978
Sponsor's protocol ID
2022-11-010-001
Status last verified
Jan 2026
First submitted
3 Jan 2023
Last updated
29 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing back-up head elevated position and neutral position in people with Intubation; Difficult or Failed, run by Hallym University Kangnam Sacred Heart Hospital at 1 site in South Korea.

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 1 inclusion and 9 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: finished, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

ease of tracheal intubation (easy/modified/unachievable) (time frame: The time from the insertion of laryngoscope into oral cavity until tracheal intubation over 1minute period). 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 NCT05671978, 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 29 Jan 2026; AzTrials last refreshed its copy on 30 Oct 2026.

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