ClinicalTrials.gg
CompletedNCT04716218Updated Jan 29, 2026

Effect of Back up Head Elevated Position on Laryngeal Visualization.

An interventional study of back up head elevated position in Intubation;Difficult, 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
64
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

In patients with limited neck extension and mouth opening due to reasons including previous radiation therapy in the head and neck area or cervical spine pathology, tracheal intubation with direct laryngoscopy (DL) are challenging because of the difficulty in aligning the oral, pharyngeal, and laryngeal axes in order to visualize the cords. In contrast, video-laryngoscopes (VL) only require alignment of the pharyngeal and laryngeal axes, which lie along much more similar angles when compared with the oral axis. Thus, VL make tracheal intubation easier to accomplish in these patients.

Good patient positioning also maximizes the chance of successful laryngoscopy and tracheal intubation. In difficult airway society 2015 guidelines, advantages of head-up positioning and ramping, which brings the patient's sternum onto the horizontal plane of the external auditory meatus (EAM), are highlighted. In the obese patient, the 'ramped' position should be used routinely because this improves the view during DL. This position is usually achieved by placing blankets or other devices under the patient's head and shoulders, but can also be achieved simply by configuring the operation room (OR) table into a back-up head elevated (BUHE) position. Significantly improved glottic views on DL have been reported with both obese and non-obese adult patients in BUHE position. However, the effect of this simple maneuver on laryngeal visualization with the VL in patients with limited neck extension and mouth opening has not been reported.

The investigators hypothesized that BUHE position might improve laryngeal views and make intubation easier compared to the supine position with the VL in patients with simulated difficult airway (application of a cervical collar to limit mouth opening and neck movement).The investigator investigated primarily the improvement in visualization of the glottis and, secondarily, the ease of tracheal intubation after alignment of the EAM and sternal notch.

02

Conditions studied

  • Intubation;Difficult
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; had a history of previous difficult direct laryngoscopy and required awake tracheal intubation; were unable or unwilling to provide ; had uncontrolled hypertension; had a history of ischaemic heart disease without optimal control of symptoms; had a history of acute or recent stroke or myocardial infarction; had cervical spine instability or cervical myelopathy; had symptomatic asthma or reactive airway disease requiring daily pharmacological treatment for control of symptoms; or had a 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
64 participants (actual)

Study arms

  • Placebo comparator
    neutral position

    The initial percentage of glottic opening (POGO) by laryngoscopy was recorded in the ramped position. Thereafter, a second POGO (laryngeal view) was scored in the neutral position and then intubation was performed.

    Procedure: back up head elevated position

  • Experimental
    back up head elevated position

    The initial POGO was recorded in the neutral position. The second POGO was scored in the ramped position and then the trachea was intubated.

    Procedure: back up head elevated position

Interventions

  • Procedureback up head elevated position

    The patient was then placed in the back-up position to align the external auditory meatus and sternal notch, which was achieved by breaking the operating table at the hips to prevent patients from sliding off the table.

06

What researchers measure

Primary outcomes

  1. POGO score

    percentage of glottic opening

    Time frame: During laryngeal visualization by laryngoscope over 1 minute 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. ease of tracheal intubation

    number of optimization procedure to facilitate laryngeal visualization and tracheal intubation

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

07

Study locations

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

References and documents

Publications

  • Chun EH, Chung MH, Kim JE, Kim KM, Lee HS, Son JM, Park J, Jun JH. Effects of head-elevated position on tracheal intubation using a McGrath MAC videolaryngoscope in patients with a simulated difficult airway: a prospective randomized crossover study. BMC Anesthesiol. 2022 May 30;22(1):166. doi: 10.1186/s12871-022-01706-5. PubMed 35637437 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2021 to primary completion in Mar 2021, 2 months.

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

Registered
Jan 12, 2021
First posted
Jan 20, 2021
StartActual
Jan 18, 2021
Primary completionActual
Mar 31, 2021
CompletionActual
Mar 31, 2021
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
NCT04716218
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 20, 2021
Start date
Jan 18, 2021
Primary completion
Mar 31, 2021
Completion
Mar 31, 2021
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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