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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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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.

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 groups in NCT07370883
Study groupRoleWhat they receive
Macintosh groupActive comparatortracheal intubation was performed using a standard Macintosh-type videolaryngoscope blade
Receives: Device: Macintosh group
Hyperangulated groupExperimentaltracheal 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.

  1. 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)
  1. 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)

  2. overall tracheal intubation success rate

    overall tracheal intubation success rate

    Measured: At the time of tracheal intubation (up to 10 min)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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.

  1. First posted27 Jan 2026
  2. Study start31 Jan 2026 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
524 participants (estimated)
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

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.

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