NCT07370883

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
524

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Jan 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress14%
Jan 2026Dec 2027

First Submitted

Initial submission to the registry

January 4, 2026

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 27, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

January 31, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

January 28, 2026

Status Verified

December 1, 2025

Enrollment Period

11 months

First QC Date

January 4, 2026

Last Update Submit

January 26, 2026

Conditions

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (8)

  • Preoperative airway assessment included the modified Mallampati classification

    before intubation (up to 10 min)

  • overall tracheal intubation success rate

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

  • the number of attempts required to achieve successful intubation

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

  • the use of adjunctive airway maneuver

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

  • time to obtain a laryngeal view with the first blade

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

  • +3 more secondary outcomes

Study Arms (2)

Macintosh group

ACTIVE COMPARATOR

tracheal intubation was performed using a standard Macintosh-type videolaryngoscope blade

Device: Macintosh group

Hyperangulated group

EXPERIMENTAL

tracheal intubation was performed using a hyperangulated videolaryngoscope blade

Device: hyperangulated group

Interventions

tracheal intubation was performed using a hyperangulated videolaryngoscope blade

Hyperangulated group

tracheal intubation was performed using a standard Macintosh-type videolaryngoscope blade

Macintosh group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2026

First Posted

January 27, 2026

Study Start

January 31, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

January 28, 2026

Record last verified: 2025-12