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

Not Applicable

Not yet recruiting

• Conditions: Intubation Complication

• Registration Number: NCT06964295
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-23
• Study First Submitted QC: 2025-04-30
• Last Update Submitted: 2025-04-30
• Study Start: 2025-05-07
• Study First Posted: 2025-05-09
• Last Update Posted: 2025-05-09
• Primary Completion: 2026-05-07
• Study Completion: 2026-05-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
First-attempt success rate of nasotracheal intubation	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 Outcome Measures

Name	Time	Method
Cormack-Lehane grade	At the time of tracheal intubation	Grading recorded during intubation to evaluate glottic exposure.
Changes in blood pressure	Within 5 minutes before and after intubation	Changes in blood pressure recorded before and after tracheal intubation.
POGO score	At the time of tracheal intubation	Visualization scores recorded during intubation to evaluate glottic exposure.
Changes in heart rate	Within 5 minutes before and after intubation	Changes in heart rate recorded before and after tracheal intubation.
Changes in saturation	Within 5 minutes before and after intubation	Changes in SpO₂ recorded before and after tracheal intubation.
Changes in bispectral value	Within 5 minutes before and after intubation	Changes in BIS values recorded before and after tracheal intubation.
Degree of subglottic injury	At the time of extubation	Graded from 0 to 3 using a flexible bronchoscope
Postoperative sore throat severity	1 hour and 24 hours postoperatively	Assessed using the Numeric Rating Scale (0-10) at 1 and 24 hours after surgery.
Incidence of postoperative hoarseness	1 hour and 24 hours postoperatively	Presence or absence of hoarseness evaluated at 1 hour and 24 hours postoperatively.