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

NCT07682480 | Not Yet Recruiting

• 1 other identifier: 2503-040-1621
• Study Type: interventional
• Target: 246
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Intubation Complication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Incidence and grade of subglottic airway injury

  Immediately after completion of surgery (at extubation)

• Postoperative sore throat score

  1 hour and 24 hours postoperatively

• Incidence of postoperative hoarseness

  1 hour and 24 hours postoperatively

• Cormack-Lehane grade and POGO score

  Periprocedural (during tracheal intubation)

• Mean blood pressure

  Periprocedural (immediately before and immediately after tracheal intubation)

Study Arms (2)

oral RAE tube group

EXPERIMENTAL

Device: endotracheal tube

reinforced tube group

ACTIVE COMPARATOR

Device: endotracheal tube

Interventions

endotracheal tube DEVICE

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.

oral RAE tube group; reinforced tube 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
• Scheduled to undergo surgery under general anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Central Study Contacts

KYUNG WON SHIN

CONTACT

02-2072-2469; skwskw126@gmail.com

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: June 21, 2026
• First Posted: July 6, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): April 17, 2027
• Study Completion (Estimated): April 17, 2028
• Last Updated: July 6, 2026

Record last verified: 2026-06