Comparison of First Attempt Success Based on Endotracheal Tube Type During Videolaryngoscope-guided Intubation Without Stylet

Comparison of First Attempt Success Based on Endotracheal Tube Type During Videolaryngoscope-guided Intubation Without Stylet: Prospective Non-inferiority Comparison

Patients are randomly assigned to either the oral RAE tube group (Group O) or the reinforced tube group (Group R). In both groups, tracheal intubation is performed using a videolaryngoscope without a stylet, and the first-attempt success rate is compared. Upon emergence from anesthesia and removal of the endotracheal tube, the degree of subglottic injury is assessed and compared between the groups. In addition, postoperative sore throat and hoarseness are evaluated and compared at 1 hour and 24 hours after surgery.

Study Overview

• Status: Not yet recruiting
• Conditions: Intubation Complication
• Intervention / Treatment: Device: endotracheal tube

• Study Type: Interventional
• Enrollment (Estimated): 246
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: KYUNG WON SHIN; Phone Number: 02-2072-2469; Email: skwskw126@gmail.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Adults aged 19 years or older
• Scheduled to undergo surgery under general anesthesia

Exclusion Criteria:

• Refusal to participate in the study
• History of gastroesophageal reflux disease
• Inadequate preoperative fasting
• Congenital or acquired upper airway abnormalities (e.g., tumors, polyps, trauma, abscesses, inflammation, foreign bodies)
• History of upper airway surgery
• High risk of aspiration or bleeding tendency
• 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: oral RAE tube group	Device: endotracheal tube; Tracheal intubation is performed using a videolaryngoscope without a stylet. In Group O, an oral RAE tube is used, while in Group R, a reinforced endotracheal tube is used. Intubation is conducted after induction of general anesthesia. Upon completion of surgery, the endotracheal tube is removed, and the degree of subglottic injury is assessed. Postoperative sore throat and hoarseness are evaluated at 1 hour and 24 hours after extubation.
Active Comparator: reinforced tube group	Device: endotracheal tube; Tracheal intubation is performed using a videolaryngoscope without a stylet. In Group O, an oral RAE tube is used, while in Group R, a reinforced endotracheal tube is used. Intubation is conducted after induction of general anesthesia. Upon completion of surgery, the endotracheal tube is removed, and the degree of subglottic injury is assessed. Postoperative sore throat and hoarseness are evaluated at 1 hour and 24 hours after extubation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First-attempt success rate of tracheal intubation	The proportion of patients in whom tracheal intubation is successfully completed on the first attempt using a videolaryngoscope without a stylet, comparing the oral RAE tube group with the reinforced tube group.	Immediately after induction of anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and grade of subglottic airway injury	Assessed using flexible bronchoscopy at the time of extubation; graded on a 0-3 scale	Immediately after completion of surgery (at extubation)
Postoperative sore throat score	Sore throat severity assessed using the Numeric Rating Scale (NRS, 0-10) at 1 and 24 hours after surgery.	1 hour and 24 hours postoperatively
Incidence of postoperative hoarseness	Binary evaluation (presence or absence) of hoarseness at 1 and 24 hours after surgery.	1 hour and 24 hours postoperatively
Cormack-Lehane grade and POGO score	Airway visualisation was assessed during tracheal intubation using the Cormack-Lehane grading system (Grade I-IV, where Grade I indicates full view of the glottis and Grade IV indicates no visible glottic structures; lower grades indicate better glottic visualisation) and the Percentage of Glottic Opening (POGO) score (0-100%, where higher scores indicate better glottic visualisation).	Periprocedural (during tracheal intubation)
Mean blood pressure		Periprocedural (immediately before and immediately after tracheal intubation)
Heart rate		Periprocedural (immediately before and immediately after tracheal intubation)
Oxygen saturation		Periprocedural (immediately before and immediately after tracheal intubation)
Bispectral index		Periprocedural (immediately before and immediately after tracheal intubation)

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): April 17, 2027
• Study Completion (Estimated): April 17, 2028

Study Registration Dates

• First Submitted: June 21, 2026
• First Submitted That Met QC Criteria: June 28, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: June 28, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2503-040-1621

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No