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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Airway Management
• Intervention / Treatment: Device: Video-assisted supraglottic airway device; Device: Conventional intubating supraglottic airway device

• Study Type: Interventional
• Enrollment (Estimated): 204
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Video-assisted Supraglottic Airway Device; Participants undergo tracheal intubation through a video-assisted supraglottic airway device without fiberoptic guidance during general anesthesia.	Device: Video-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.; Other Names: SaCo VLM
Active Comparator: Conventional Supraglottic Airway Device; Participants undergo tracheal intubation through a conventional intubating supraglottic airway device without fiberoptic guidance during general anesthesia.	Device: Conventional 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.; Other Names: AirQ

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At the time of tracheal intubation during induction of general anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intubation time	Time required for tracheal intubation through the assigned supraglottic airway device.	During induction of general anesthesia
Number of intubation attempts	Number of attempts required to achieve successful tracheal intubation through the assigned supraglottic airway device.	During induction of general anesthesia
Overall intubation success rate	Proportion of participants with successful tracheal intubation through the assigned supraglottic airway device regardless of the number of attempts.	During induction of general anesthesia
Postoperative sore throat	Incidence and severity of postoperative sore throat.	1 hour and 24 hours after surgery
Postoperative hoarseness	Incidence of postoperative hoarseness.	1 hour and 24 hours after surgery

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2029

Study Registration Dates

• First Submitted: July 9, 2026
• First Submitted That Met QC Criteria: July 9, 2026
• First Posted (Actual): July 15, 2026

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 9, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2605-119-1747

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No