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NCT Number: NCT07682480

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

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.

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Key information

Conditions

Intubation Complication

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. First-attempt success rate of tracheal intubation

    Time frame: Immediately after induction of anesthesia

    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.

Secondary outcomes

  1. Incidence and grade of subglottic airway injury

    Time frame: Immediately after completion of surgery (at extubation)

    Assessed using flexible bronchoscopy at the time of extubation; graded on a 0-3 scale

  2. Postoperative sore throat score

    Time frame: 1 hour and 24 hours postoperatively

    Sore throat severity assessed using the Numeric Rating Scale (NRS, 0-10) at 1 and 24 hours after surgery.

  3. Incidence of postoperative hoarseness

    Time frame: 1 hour and 24 hours postoperatively

    Binary evaluation (presence or absence) of hoarseness at 1 and 24 hours after surgery.

  4. Cormack-Lehane grade and POGO score

    Time frame: Periprocedural (during tracheal intubation)

    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).

  5. Mean blood pressure

    Time frame: Periprocedural (immediately before and immediately after tracheal intubation)

  6. Heart rate

    Time frame: Periprocedural (immediately before and immediately after tracheal intubation)

  7. Oxygen saturation

    Time frame: Periprocedural (immediately before and immediately after tracheal intubation)

  8. Bispectral index

    Time frame: Periprocedural (immediately before and immediately after tracheal intubation)

Study contacts

Contact information is provided by the study sponsor or research team.

KYUNG WON SHIN

CONTACT

[email protected]

02-2072-2469

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 6, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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