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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Intubation Complication
• Intervention / Treatment: Device: Macintosh videolaryngoscope; Device: Flexible bronchoscope

• Study Type: Interventional
• Enrollment (Estimated): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Videolaryngoscope Group	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.
Active Comparator: Flexible Bronchoscope Group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First-attempt success rate of nasotracheal 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.	At the time of tracheal intubation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2025
• Primary Completion (Estimated): May 7, 2026
• Study Completion (Estimated): May 7, 2026

Study Registration Dates

• First Submitted: April 23, 2025
• First Submitted That Met QC Criteria: April 30, 2025
• First Posted (Actual): May 9, 2025

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2503-041-1621

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No