First Attempt Success in Tracheal Intubation Through Supraglottic Airway Devices Without Fiberoptic Guidance

NCT07704723 — Not applicable, Not yet recruiting, 204 participants, Seoul National University Hospital

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First Attempt Success in Tracheal Intubation Through Supraglottic Airway Devices Without Fiberoptic Guidance: Conventional vs. Video-assisted Supraglottic Airway Devices, a Randomized Controlled Trial

Registry	NCT07704723
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	204 (Estimated)
Sponsor	Seoul National University Hospital (Other)
Conditions	Airway Management
Interventions	Video-assisted supraglottic airway device, Conventional intubating supraglottic airway device (Device)
Dates	start 2026-08-01 (estimated), primary completion 2028-08-01 (estimated), completion 2029-08-01 (estimated), first posted 2026-07-15, last updated 2026-07-15

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Video-assisted Supraglottic Airway Device	Experimental	Device: Video-assisted supraglottic airway device	Participants undergo tracheal intubation through a video-assisted supraglottic airway device without fiberoptic guidance during general anesthesia.
Conventional Supraglottic Airway Device	Active comparator	Device: Conventional intubating supraglottic airway device	Participants undergo tracheal intubation through a conventional intubating supraglottic airway device without fiberoptic guidance during general anesthesia.

Video-assisted supraglottic airway device (Device), also known as SaCo VLM: A 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 (Device), also known as AirQ: A conventional intubating supraglottic airway device is inserted after induction of general anesthesia, and tracheal intubation is performed through the device without fiberoptic guidance.

+Outcome measures

Primary outcomes

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 outcomes

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.

+Eligibility

Sex: All, ages: 19 Years to any

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.