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Not yet recruiting NCT07370883

Personalized Selection of Hyperangulated vs. Macintosh Videolaryngoscope Blades

No phase Interventional Airway Assessment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Macintosh group, hyperangulated group.
Who it may be relevant to
Registry conditions: Airway Assessment. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Personalized Selection of Hyperangulated vs. Macintosh Videolaryngoscope Blades: Randomized Controlled Trial and Development of an Integrated Predictive Algorithm

Overview

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.

Interventions

  • Device Macintosh group
    tracheal intubation was performed using a standard Macintosh-type videolaryngoscope blade
  • Device hyperangulated group
    tracheal intubation was performed using a hyperangulated videolaryngoscope blade

Primary outcome measures

  • first attempt success rate [Time frame: At the time of tracheal intubation (up to 10 min)]
Secondary outcome measures (8)
  • 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)]

Eligibility criteria

Inclusion criteria

  • Adult patients aged ≥ 19 years undergoing surgery under general anesthesia.

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07370883 · 2510-078-1683

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗