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Enrolling by Invitation

NCT Number: NCT06964295

Comparison of First Attempt Success in Nasotracheal Intubation Using Macintosh Videolaryngoscope vs. Flexible Bronchoscope

Participants are randomly assigned to two groups: one group undergoes nasotracheal intubation using a videolaryngoscope, while the other group undergoes nasotracheal intubation using a flexible bronchoscope. The primary outcome is the first-attempt success rate, assessed at the time of tracheal tube placement. Additional outcomes include the degree of subglottic injury upon extubation, and the incidence and severity of sore throat and hoarseness at 1 hour and 24 hours postoperatively, as well as overall intubation success rates.

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Key information

Conditions

Intubation Complication

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 19 years or older
  • Undergoing ear, nose, and throat (ENT) surgery requiring nasotracheal intubation

Exclusion criteria

  • Refusal to participate in the study
  • History of gastroesophageal reflux disease
  • History of surgery or radiation therapy involving the upper airway
  • Presence of severely loose teeth

Treatment and study plan

Macintosh videolaryngoscope

Device

Used to perform nasotracheal intubation under general anesthesia. The Macintosh videolaryngoscope is introduced orally to visualize the glottis, and a preformed nasotracheal tube is inserted through the nostril.

Flexible bronchoscope

Device

Used to perform nasotracheal intubation under general anesthesia. The bronchoscope is inserted through a lubricated nasotracheal tube and advanced into the trachea.

Primary outcomes

  1. First-attempt success rate of nasotracheal intubation

    Time frame: At the time of tracheal intubation

    The proportion of patients in whom nasotracheal intubation is successfully completed on the first attempt, comparing the videolaryngoscope group with the flexible bronchoscope group.

Secondary outcomes

  1. Degree of subglottic injury

    Time frame: At the time of extubation

    Graded from 0 to 3 using a flexible bronchoscope. Higher scores mean a worse outcome (more severe subglottic injury).

  2. Postoperative sore throat severity

    Time frame: 1 hour and 24 hours postoperatively

    Assessed using the Numeric Rating Scale (0-10) at 1 and 24 hours after surgery.

  3. Incidence of postoperative hoarseness

    Time frame: 1 hour and 24 hours postoperatively

    Presence or absence of hoarseness evaluated at 1 hour and 24 hours postoperatively.

  4. Cormack-Lehane grade

    Time frame: At the time of tracheal intubation

    Grading recorded during intubation to evaluate glottic exposure.

  5. Changes in blood pressure

    Time frame: Within 5 minutes before and after intubation

    Changes in blood pressure recorded before and after tracheal intubation.

  6. POGO score

    Time frame: At the time of tracheal intubation

    Visualization scores recorded during intubation to evaluate glottic exposure. The score ranges from 0% (no glottic visualization) to 100% (full view of the glottis). Higher scores indicate a better outcome (better visualization).

  7. Changes in heart rate

    Time frame: Within 5 minutes before and after intubation

    Changes in heart rate recorded before and after tracheal intubation.

  8. Changes in saturation

    Time frame: Within 5 minutes before and after intubation

    Changes in SpO₂ recorded before and after tracheal intubation.

  9. Changes in bispectral value

    Time frame: Within 5 minutes before and after intubation

    Changes in BIS values recorded before and after tracheal intubation.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Comparison of First Attempt Success in Nasotracheal Intubation Using Macintosh Videolaryngoscope vs. Flexible Bronchoscope: a Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 9, 2025
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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