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Enrolling by invitation NCT06964295

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

No phase Interventional Intubation Complication

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 videolaryngoscope, Flexible bronchoscope.
Who it may be relevant to
Registry conditions: Intubation Complication. 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
South Korea
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

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

Overview

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.

Interventions

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

Primary outcome measures

  • First-attempt success rate of nasotracheal intubation [Time frame: At the time of tracheal intubation]
Secondary outcome measures (9)
  • Degree of subglottic injury [Time frame: At the time of extubation]
  • Postoperative sore throat severity [Time frame: 1 hour and 24 hours postoperatively]
  • Incidence of postoperative hoarseness [Time frame: 1 hour and 24 hours postoperatively]
  • Cormack-Lehane grade [Time frame: At the time of tracheal intubation]
  • Changes in blood pressure [Time frame: Within 5 minutes before and after intubation]
  • POGO score [Time frame: At the time of tracheal intubation]
  • Changes in heart rate [Time frame: Within 5 minutes before and after intubation]
  • Changes in saturation [Time frame: Within 5 minutes before and after intubation]
  • Changes in bispectral value [Time frame: Within 5 minutes before and after intubation]

Eligibility criteria

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

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

South Korea · 1 center
  • Seoul National University Hospital — Seoul

Identifiers

NCT: NCT06964295 · 2503-041-1621

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗