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

NCT06964295 | Enrolling By Invitation

• 1 other identifier: 2503-041-1621
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Intubation Complication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Degree of subglottic injury

  At the time of extubation

• Postoperative sore throat severity

  1 hour and 24 hours postoperatively

• Incidence of postoperative hoarseness

  1 hour and 24 hours postoperatively

• Cormack-Lehane grade

  At the time of tracheal intubation

• Changes in blood pressure

  Within 5 minutes before and after intubation

Study Arms (2)

Videolaryngoscope Group

EXPERIMENTAL

Device: Macintosh videolaryngoscope

Flexible Bronchoscope Group

ACTIVE COMPARATOR

Device: Flexible bronchoscope

Interventions

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.

Videolaryngoscope Group

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.

Flexible Bronchoscope Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

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: April 23, 2025
• First Posted: May 9, 2025
• Study Start: May 9, 2025
• Primary Completion: May 7, 2026
• Study Completion: May 7, 2026
• Last Updated: January 28, 2026

Record last verified: 2025-04

Locations

KR (1)