Intubation Complication
Conditions
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.
Interventions
DEVICEendotracheal 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.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First-attempt success rate of tracheal intubation | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence and grade of subglottic airway injury | Immediately after completion of surgery (at extubation) | Assessed using flexible bronchoscopy at the time of extubation; graded on a 0-3 scale |
| Postoperative sore throat score | 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. |
| Incidence of postoperative hoarseness | 1 hour and 24 hours postoperatively | Binary evaluation (presence or absence) of hoarseness at 1 and 24 hours after surgery. |
| Cormack-Lehane grade and POGO score | 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). |
| 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) | — |
Contacts
CONTACTKYUNG WON SHIN
Outcome results
None listed