Airway Management
Conditions
Brief summary
This randomized controlled trial aims to compare the first-attempt success rate of tracheal intubation through supraglottic airway devices using a conventional intubating supraglottic airway device versus a video-assisted supraglottic airway device without fiberoptic guidance in adult patients undergoing elective surgery under general anesthesia. A total of 204 participants will be randomly assigned to one of the two groups. The primary outcome is the first-attempt success rate of tracheal intubation through the supraglottic airway device. Secondary outcomes include intubation time, number of intubation attempts, overall intubation success, hemodynamic changes, airway-related complications, postoperative sore throat and hoarseness, and adverse events. The results of this study may help identify a safe and effective airway management strategy when fiberoptic bronchoscopy is unavailable.
Interventions
DEVICEVideo-assisted supraglottic airway device
A video-assisted supraglottic airway device is inserted after induction of general anesthesia, and tracheal intubation is performed through the device without fiberoptic guidance.
DEVICEConventional intubating supraglottic airway device
A conventional intubating supraglottic airway device is inserted after induction of general anesthesia, and tracheal intubation is performed through the device without fiberoptic guidance.
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 elective surgery under general anesthesia requiring tracheal intubation.
Exclusion criteria
* Refusal or inability to provide informed consent. * Emergency surgery. * History of gastroesophageal reflux disease. * Previous surgery or radiotherapy involving the upper airway. * Severely loose teeth. * Any condition considered by the investigator to make study participation inappropriate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First-attempt success rate of tracheal intubation through the supraglottic airway device | At the time of tracheal intubation during induction of general anesthesia | The proportion of participants in whom tracheal intubation through the assigned supraglottic airway device is successfully achieved on the first attempt without fiberoptic guidance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intubation time | During induction of general anesthesia | Time required for tracheal intubation through the assigned supraglottic airway device. |
| Number of intubation attempts | During induction of general anesthesia | Number of attempts required to achieve successful tracheal intubation through the assigned supraglottic airway device. |
| Overall intubation success rate | During induction of general anesthesia | Proportion of participants with successful tracheal intubation through the assigned supraglottic airway device regardless of the number of attempts. |
| Postoperative sore throat | 1 hour and 24 hours after surgery | Incidence and severity of postoperative sore throat. |
| Postoperative hoarseness | 1 hour and 24 hours after surgery | Incidence of postoperative hoarseness. |
Outcome results
None listed