Endotracheal IntubationNCT05495880
Forearm-Supported Head Extension to Decrease Dental Contact
A study testing Laryngoscopy with forearm-support and Laryngoscopy without forearm-support in people with Endotracheal Intubation, run by Seoul National University Hospital.
Trial summary
The purpose of this study is to determine whether the forearm-supported head extension decreases dental contact between laryngoscope blade and maxillary incisors during direct laryngoscopy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endotracheal Intubation
- What is being tested?
- Laryngoscopy with forearm-support and Laryngoscopy without forearm-support
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 18 May 2023to 31 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing surgery that require endotracheal intubation for general anesthesia
Who cannot join
- Trauma or disease or cervical spine
- Toothless patient
- Dentoalveolar injury
- Anatomical anomaly of face or airway
- History of difficult intubation
- Patient refusal
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Forearm-Supported Head Extension to Decrease Dental Contact Between Laryngoscope Blade and Maxillary Incisors During Direct Laryngoscopy
The purpose of this study is to determine whether the forearm-supported head extension decreases dental contact between laryngoscope blade and maxillary incisors during direct laryngoscopy
- Conditions
- Endotracheal Intubation
- Being tested
- Laryngoscopy with forearm-support, Laryngoscopy without forearm-support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laryngoscopy with forearm-supportProcedure or surgery
forearm-supported head extension during direct laryngoscopy
Laryngoscopy without forearm-supportProcedure or surgery
without forearm-support for head extension during direct laryngoscopy
| Study group | Role | What they receive |
|---|---|---|
| Forearm-supported | Experimental | forearm-supported head extension during direct laryngoscopy Receives: Procedure: Laryngoscopy with forearm-support |
| Control | Active comparator | without forearm-support for head extension during direct laryngoscopy Receives: Procedure: Laryngoscopy without forearm-support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental contact
Dental contact between laryngoscope blade and maxillary incisors (Y/N)
Measured: during laryngoscopy
Secondary outcomes (2)
Blade-to-tooth distance
Teeth distance between laryngoscope blade and maxillary incisors (mm)
Measured: during laryngoscopy
Angle of head extension
Angle of head extension during direct laryngoscopy
Measured: during laryngoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start18 May 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
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 Endotracheal IntubationStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495880
- Sponsor's protocol ID
- JHBahk_novel_intu
- Status last verified
- Aug 2022
- First submitted
- 8 Aug 2022
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Song SE, Ju JW, Park JY, Park D, Yoon S, Nam K, Lee HJ, Seo JH, Kim WH, Bahk JH. Forearm support to reduce dental contact during direct laryngoscopy: a randomized crossover trial. Can J Anaesth. 2025 Oct;72(10):1511-1520. doi: 10.1007/s12630-025-03035-w. Epub 2025 Oct 13.
PubMed 41083757
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Forearm-Supported Head Extension to Decrease Dental Contact Between Laryngoscope Blade and Maxillary Incisors During Direct Laryngoscopy
- ClinicalTrials.gov ID
- NCT05495880
- Acronym / sponsor ID
- JHBahk_novel_intu
- Conditions
- Endotracheal Intubation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 18 May 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 10 Aug 2022 (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 purpose of this study is to determine whether the forearm-supported head extension decreases dental contact between laryngoscope blade and maxillary incisors during direct laryngoscopy
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Forearm-supported | Experimental | Procedure: Laryngoscopy with forearm-supportforearm-supported head extension during direct laryngoscopy |
| Control | Active comparator | Procedure: Laryngoscopy without forearm-supportwithout forearm-support for head extension during direct laryngoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing surgery that require endotracheal intubation for general anesthesia
Key exclusion criteria (6 listed)
- Trauma or disease or cervical spine
- Toothless patient
- Dentoalveolar injury
- Anatomical anomaly of face or airway
- History of difficult intubation
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 |
|---|---|---|
| Laryngoscopy with forearm-supportforearm-supported head extension during direct laryngoscopy | Procedure or surgery | Forearm-supported |
| Laryngoscopy without forearm-supportwithout forearm-support for head extension during direct laryngoscopy | Procedure or surgery | Control |
Primary outcome
Dental contact
Time frame: during laryngoscopy
Dental contact between laryngoscope blade and maxillary incisors (Y/N)
2 secondary outcomes
Blade-to-tooth distance
Time frame: during laryngoscopy
Angle of head extension
Time frame: during laryngoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Derived from this study: PubMed 41083757Song SE, Ju JW, Park JY, Park D, Yoon S, Nam K, Lee HJ, Seo JH, Kim WH, Bahk JH. Forearm support to reduce dental contact during direct laryngoscopy: a randomized crossover trial. Can J Anaesth. 2025 Oct;72(10):1511-1520. doi: 10.1007/s12630-025-03035-w. Epub 2025 Oct 13.
- Individual participant dataSharing planned: No
Related trials for Endotracheal Intubation
Recruiting
Hyperangulated vs Standard Videolaryngoscopy vs Direct Laryngoscopy for Double-Lumen Endobronchial Tube Intubation
Endobronchial Intubation, Double Lumen Tube Intubation
Recruiting
Hyperangulated vs. Macintosh Style Blades for Intubation in Obstetric Patients
Obstetric, Cesarean Birth
Not yet recruiting
AI Smart Glasses Feedback for Intubation Training in Medical Students
Intubation, Intratracheal, Medical Education
Not yet recruiting
Effect of a Brief Educational Intervention on Endotracheal Tube Cuff Pressure
Intubation, Endotracheal Tube Cuff Pressure
Not yet recruitingObservational study
Patient State Index at Laryngoscopy and Tracheal Intubation Conditions
Anesthesia, Intubation, Endotracheal
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.
Questions about this trial
What is this clinical trial studying?
A study testing Laryngoscopy with forearm-support and Laryngoscopy without forearm-support in people with Endotracheal Intubation, run by Seoul National University Hospital.
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 6 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: status not confirmed, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jae-Hyon Bahk, MD PhD (82-2-2072-2818, bahkjh@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental contact (time frame: during laryngoscopy). 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 NCT05495880, 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 May 2023.