About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 19 years or older
Scheduled to undergo surgery under general anesthesia
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
endotracheal tube
DeviceTracheal 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Incidence and grade of subglottic airway injury
Assessed using flexible bronchoscopy at the time of extubation; graded on a 0-3 scale
Postoperative sore throat score
Sore throat severity assessed using the Numeric Rating Scale (NRS, 0-10) at 1 and 24 hours after surgery.
Incidence of postoperative hoarseness
Binary evaluation (presence or absence) of hoarseness at 1 and 24 hours after surgery.
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).
Locations
Sponsors and contacts
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