About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 19 years or older.
Scheduled to undergo elective surgery under general anesthesia requiring tracheal intubation.
Disqualifiers
Refusal or inability to provide informed consent.
Emergency surgery.
History of gastroesophageal reflux disease.
Previous surgery or radiotherapy involving the upper airway.
Trial design
Parallel
Treatments tested in this trial
Video-assisted supraglottic airway device
DeviceA video-assisted supraglottic airway device is inserted after induction of general anesthesia, and tracheal intubation is performed through the device without fiberoptic guidance.
Conventional intubating supraglottic airway device
DeviceA conventional intubating supraglottic airway device is inserted after induction of general anesthesia, and tracheal intubation is performed through the device without fiberoptic guidance.
Treatment groups
Trial outcomes
Primary outcomes
First-attempt success rate of tracheal intubation through the supraglottic airway device
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 outcomes
Intubation time
Time required for tracheal intubation through the assigned supraglottic airway device.
Number of intubation attempts
Number of attempts required to achieve successful tracheal intubation through the assigned supraglottic airway device.
Overall intubation success rate
Proportion of participants with successful tracheal intubation through the assigned supraglottic airway device regardless of the number of attempts.
Postoperative sore throat
Incidence and severity of postoperative sore throat.
Locations
Sponsors and contacts
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