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.
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.
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.
- Conditions
- Intubation; Difficult or Failed
- 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 group | Role | What they receive |
|---|---|---|
| neutral position | Placebo comparator | intubation was performed in the neutral position Receives: Procedure: neutral position |
| back-up head elevated position | Experimental | he 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.
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)
intubation time
time required for intubation
Measured: : The time from the insertion of laryngoscope into oral cavity until its removal over 1 minute period
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.
- First posted5 Jan 2023
- Study start16 Jan 2023
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
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 Intubation; Difficult or FailedStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hallym University Kangnam Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun joohyun, Hallym University Kangnam Sacred Heart Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Head Elevated Position on Ease of Tracheal Intubation Using Hyper-angulated Video-laryngoscope in Patients With Simulated Difficult Airway
- ClinicalTrials.gov ID
- NCT05671978
- Acronym / sponsor ID
- 2022-11-010-001
- Conditions
- Intubation; Difficult or Failed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Hallym University Kangnam Sacred Heart HospitalUniversity, hospital or other
- Study start
- 16 Jan 2023 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 5 Jan 2023 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neutral position | Placebo comparator | Procedure: neutral positionintubation was performed in the neutral position |
| back-up head elevated position | Experimental | Procedure: back-up head elevated positionhe trachea was intubated in the back-up head elevated position |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients of ASA physical status 1-2 who were scheduled for elective surgery under general anaesthesia requiring tracheal intubation.
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| back-up head elevated positionThe 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 | Procedure or surgery | back-up head elevated position |
| neutral positionThe patient was then placed in the netural position | Procedure or surgery | neutral position |
Primary outcome
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
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
2 secondary outcomes
intubation time
Time frame: : The time from the insertion of laryngoscope into oral cavity until its removal over 1 minute period
percentage of glottic opening (POGO) score (0-100%)
Time frame: During laryngeal visualization by laryngoscope over 1 minute period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Derived from this study: PubMed 41349843Lee 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.