Airway AssessmentHAVLNCT07370883
Personalized Selection of Hyperangulated vs. Macintosh Videolaryngoscope Blades
A study testing Macintosh group and hyperangulated group in people with Airway Assessment, run by Seoul National University Hospital.
Trial summary
This study aims to determine whether hyperangulated blades have a higher intubation success rate than Macintosh blades in patients undergoing general anesthesia, and to identify patient subgroups in which hyperangulated blades are particularly advantageous for tracheal intubation. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Airway Assessment
- What is being tested?
- Macintosh group and hyperangulated group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 524 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged ≥ 19 years undergoing surgery under general anesthesia.
Who cannot join
- Patients who did not provide informed consent
- Patients with severely loose or unstable teeth
- Patients with cervical spine disease
- Patients with American Society of Anesthesiologists (ASA) physical status class IV or higher
- Pregnant women
- Patients with head and neck cancer
- Patients who had previous radiotherapy for head and neck cancer
- Patients deemed unsuitable for study participation at the investigator's discretion
About this study
Official title: Personalized Selection of Hyperangulated vs. Macintosh Videolaryngoscope Blades: Randomized Controlled Trial and Development of an Integrated Predictive Algorithm
This study aims to determine whether hyperangulated blades have a higher intubation success rate than Macintosh blades in patients undergoing general anesthesia, and to identify patient subgroups in which hyperangulated blades are particularly advantageous for tracheal intubation.
Read the detailed description
Randomized controlled trial
This study was designed as a randomized controlled trial. A total of 524 patients were randomly allocated in a 1:1 ratio to either the hyperangulated blade group (H group) or the Macintosh blade group (M group).
The primary endpoint was first-attempt intubation success. The secondary endpoints included the overall tracheal intubation success rate, the number of intubation attempts, time for the tracheal tube to pass through the vocal cords (T5), time to ventilation (T6), and the use of adjunctive airway maneuvers (e.g., external laryngeal manipulation [ELM]).
Between-group comparisons were performed according to the characteristics of each endpoint. Categorical variables were analyzed using the χ² test or Fisher's exact test, as appropriate, and results were presented as risk ratios (RRs) with 95% confidence intervals (CIs). Continuous variables were assessed for normality using the Shapiro-Wilk test. Normally distributed variables were compared using the independent-samples t-test, whereas non-normally distributed variables were analyzed using the Mann-Whitney U test. Results were reported as mean or median differences with 95% CIs.
All study participants experienced both videolaryngoscope blades. However, actual tracheal intubation was performed only with the second blade, while the first blade was used solely for assessment of glottic view and approach times. To minimize learning-related order effects, each attempt was performed by a different investigator, and each investigator was restricted to using only the blade assigned to them. In addition, within-patient comparisons of POGO scores, approach times, and visualization difficulty between the first and second blades were conducted to analyze blade-specific visualization characteristics. If significant differences were observed, potential order effects were further evaluated during the analysis.
Within-patient comparison (paired evaluation)
Before actual tracheal intubation, glottic visualization up to just before the vocal cords was assessed using both blades in all participants. The order of blade use was balanced according to randomization: patients in the M group underwent visualization assessment in the H→M sequence followed by intubation with the Macintosh blade, whereas patients in the H group underwent visualization assessment in the M→H sequence followed by intubation with the hyperangulated blade. Accordingly, within-patient comparisons were conducted using visualization data obtained in the predefined sequence for each group, thereby minimizing order effects.
The evaluated parameters included:
(i) time to obtain a laryngeal view (T1/T3), (ii) time for the tracheal tube tip to reach the vocal cords (T2/T4), (iii) VIDIAC score, (iv) percentage of glottic opening (POGO) score, (v) operator-reported subjective difficulty score, and (vi) complications (e.g., SpO₂ < 90%, dental or soft-tissue injury).
Differences in continuous paired outcomes between the hyperangulated and Macintosh blades were analyzed using the paired t-test or Wilcoxon signed-rank test, as appropriate. When classifying each outcome according to which blade was superior (hyperangulated-favored, Macintosh-favored, or equivalent), McNemar's test was used for binary classifications and the Stuart-Maxwell test for three-category classifications.
Machine learning-based exploratory analysis
Finally, data obtained from the randomized controlled trial and paired analyses were further leveraged to explore, in an exploratory manner, which blade may be more advantageous under specific anatomical and demographic conditions. Outcomes that demonstrated between-group differences in the primary or secondary analyses were selected as target variables. All covariates were included as input features, and an XGBoost-based ensemble tree model was trained.
Model performance was evaluated using the area under the receiver operating characteristic curve (AUROC) with 95% CIs for binary outcomes and root mean squared error (RMSE) and mean absolute error (MAE) for continuous outcomes. SHapley Additive exPlanations (SHAP) analysis was performed to visualize feature importance and interaction patterns, and decision curve analysis (DCA) was used to assess the clinical net benefit of the predictive models.
- Conditions
- Airway Assessment
- Being tested
- Macintosh group, hyperangulated group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macintosh groupDevice
tracheal intubation was performed using a standard Macintosh-type videolaryngoscope blade
hyperangulated groupDevice
tracheal intubation was performed using a hyperangulated videolaryngoscope blade
| Study group | Role | What they receive |
|---|---|---|
| Macintosh group | Active comparator | tracheal intubation was performed using a standard Macintosh-type videolaryngoscope blade Receives: Device: Macintosh group |
| Hyperangulated group | Experimental | tracheal intubation was performed using a hyperangulated videolaryngoscope blade Receives: Device: hyperangulated group |
What is being measured
The primary outcome is the main question the study is designed to answer.
first attempt success rate
successful placement of the tracheal tube into the airway on the first attempt within 60 seconds, without the need for assistance from another operator or the use of adjunctive airway maneuvers.
Measured: At the time of tracheal intubation (up to 10 min)
Secondary outcomes (8)
Preoperative airway assessment included the modified Mallampati classification
Class I: soft palate, fauces, pillars, and uvula visible; Class II: soft palate, fauces, and uvula visible; Class III: soft palate and base of the uvula visible; Class IV: soft palate not visible
Measured: before intubation (up to 10 min)
overall tracheal intubation success rate
overall tracheal intubation success rate
Measured: At the time of tracheal intubation (up to 10 min)
the number of attempts required to achieve successful intubation
the number of attempts required to achieve successful intubation
Measured: At the time of tracheal intubation (up to 10 min)
the use of adjunctive airway maneuver
the use of adjunctive airway maneuvers, such as external laryngeal manipulation (ELM)
Measured: At the time of tracheal intubation (up to 10 min)
time to obtain a laryngeal view with the first blade
T1: from insertion of the laryngoscope to visualization of the glottis
Measured: At the time of tracheal intubation (up to 10 min)
time for the tracheal tube to reach the vocal cords with the first blade
T2: from laryngoscope insertion to advancement of the tube to just before the vocal cords
Measured: At the time of tracheal intubation (up to 10 min)
time to obtain a laryngeal view with the second blade
T3: from laryngoscope insertion to visualization of the glottis
Measured: At the time of tracheal intubation (up to 10 min)
time for the tracheal tube to reach the vocal cords with the second blade
T4: from laryngoscope insertion to advancement of the tube to just before the vocal cords
Measured: At the time of tracheal intubation (up to 10 min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start31 Jan 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway AssessmentStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 524 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
- NCT07370883
- Sponsor's protocol ID
- 2510-078-1683
- Acronym
- HAVL
- Status last verified
- Dec 2025
- First submitted
- 4 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Selection of Hyperangulated vs. Macintosh Videolaryngoscope Blades: Randomized Controlled Trial and Development of an Integrated Predictive Algorithm
- ClinicalTrials.gov ID
- NCT07370883
- Acronym / sponsor ID
- HAVL / 2510-078-1683
- Conditions
- Airway Assessment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 524 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 31 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Jan 2026 (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.
This study aims to determine whether hyperangulated blades have a higher intubation success rate than Macintosh blades in patients undergoing general anesthesia, and to identify patient subgroups in which hyperangulated blades are particularly advantageous for tracheal intubation.
Detailed description
Randomized controlled trial
This study was designed as a randomized controlled trial. A total of 524 patients were randomly allocated in a 1:1 ratio to either the hyperangulated blade group (H group) or the Macintosh blade group (M group).
The primary endpoint was first-attempt intubation success. The secondary endpoints included the overall tracheal intubation success rate, the number of intubation attempts, time for the tracheal tube to pass through the vocal cords (T5), time to ventilation (T6), and the use of adjunctive airway maneuvers (e.g., external laryngeal manipulation [ELM]).
Between-group comparisons were performed according to the characteristics of each endpoint. Categorical variables were analyzed using the χ² test or Fisher's exact test, as appropriate, and results were presented as risk ratios (RRs) with 95% confidence intervals (CIs). Continuous variables were assessed for normality using the Shapiro-Wilk test. Normally distributed variables were compared using the independent-samples t-test, whereas non-normally distributed variables were analyzed using the Mann-Whitney U test. Results were reported as mean or median differences with 95% CIs.
All study participants experienced both videolaryngoscope blades. However, actual tracheal intubation was performed only with the second blade, while the first blade was used solely for assessment of glottic view and approach times. To minimize learning-related order effects, each attempt was performed by a different investigator, and each investigator was restricted to using only the blade assigned to them. In addition, within-patient comparisons of POGO scores, approach times, and visualization difficulty between the first and second blades were conducted to analyze blade-specific visualization characteristics. If significant differences were observed, potential order effects were further evaluated during the analysis.
Within-patient comparison (paired evaluation)
Before actual tracheal intubation, glottic visualization up to just before the vocal cords was assessed using both blades in all participants. The order of blade use was balanced according to randomization: patients in the M group underwent visualization assessment in the H→M sequence followed by intubation with the Macintosh blade, whereas patients in the H group underwent visualization assessment in the M→H sequence followed by intubation with the hyperangulated blade. Accordingly, within-patient comparisons were conducted using visualization data obtained in the predefined sequence for each group, thereby minimizing order effects.
The evaluated parameters included:
(i) time to obtain a laryngeal view (T1/T3), (ii) time for the tracheal tube tip to reach the vocal cords (T2/T4), (iii) VIDIAC score, (iv) percentage of glottic opening (POGO) score, (v) operator-reported subjective difficulty score, and (vi) complications (e.g., SpO₂ < 90%, dental or soft-tissue injury).
Differences in continuous paired outcomes between the hyperangulated and Macintosh blades were analyzed using the paired t-test or Wilcoxon signed-rank test, as appropriate. When classifying each outcome according to which blade was superior (hyperangulated-favored, Macintosh-favored, or equivalent), McNemar's test was used for binary classifications and the Stuart-Maxwell test for three-category classifications.
Machine learning-based exploratory analysis
Finally, data obtained from the randomized controlled trial and paired analyses were further leveraged to explore, in an exploratory manner, which blade may be more advantageous under specific anatomical and demographic conditions. Outcomes that demonstrated between-group differences in the primary or secondary analyses were selected as target variables. All covariates were included as input features, and an XGBoost-based ensemble tree model was trained.
Model performance was evaluated using the area under the receiver operating characteristic curve (AUROC) with 95% CIs for binary outcomes and root mean squared error (RMSE) and mean absolute error (MAE) for continuous outcomes. SHapley Additive exPlanations (SHAP) analysis was performed to visualize feature importance and interaction patterns, and decision curve analysis (DCA) was used to assess the clinical net benefit of the predictive models.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Macintosh group | Active comparator | Device: Macintosh grouptracheal intubation was performed using a standard Macintosh-type videolaryngoscope blade |
| Hyperangulated group | Experimental | Device: hyperangulated grouptracheal intubation was performed using a hyperangulated videolaryngoscope blade |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients aged ≥ 19 years undergoing surgery under general anesthesia.
Key exclusion criteria (8 listed)
- Patients who did not provide informed consent
- Patients with severely loose or unstable teeth
- Patients with cervical spine disease
- Patients with American Society of Anesthesiologists (ASA) physical status class IV or higher
- Pregnant women
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 |
|---|---|---|
| Macintosh grouptracheal intubation was performed using a standard Macintosh-type videolaryngoscope blade | Device | Macintosh group |
| hyperangulated grouptracheal intubation was performed using a hyperangulated videolaryngoscope blade | Device | Hyperangulated group |
Primary outcome
first attempt success rate
Time frame: At the time of tracheal intubation (up to 10 min)
successful placement of the tracheal tube into the airway on the first attempt within 60 seconds, without the need for assistance from another operator or the use of adjunctive airway maneuvers.
8 secondary outcomes
Preoperative airway assessment included the modified Mallampati classification
Time frame: before intubation (up to 10 min)
overall tracheal intubation success rate
Time frame: At the time of tracheal intubation (up to 10 min)
the number of attempts required to achieve successful intubation
Time frame: At the time of tracheal intubation (up to 10 min)
the use of adjunctive airway maneuver
Time frame: At the time of tracheal intubation (up to 10 min)
time to obtain a laryngeal view with the first blade
Time frame: At the time of tracheal intubation (up to 10 min)
time for the tracheal tube to reach the vocal cords with the first blade
Time frame: At the time of tracheal intubation (up to 10 min)
time to obtain a laryngeal view with the second blade
Time frame: At the time of tracheal intubation (up to 10 min)
time for the tracheal tube to reach the vocal cords with the second blade
Time frame: At the time of tracheal intubation (up to 10 min)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Macintosh group and hyperangulated group in people with Airway Assessment, 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 8 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: opening soon, as of the sponsor's last update on 28 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
first attempt success rate (time frame: At the time of tracheal intubation (up to 10 min)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2026.