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

NCT07704723 | Not Yet Recruiting

• 1 other identifier: 2605-119-1747
• Study Type: interventional
• Target: 204
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Airway Management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Intubation time

  During induction of general anesthesia

• Number of intubation attempts

  During induction of general anesthesia

• Overall intubation success rate

  During induction of general anesthesia

• Postoperative sore throat

  1 hour and 24 hours after surgery

• Postoperative hoarseness

  1 hour and 24 hours after surgery

Study Arms (2)

Video-assisted Supraglottic Airway Device

EXPERIMENTAL

Participants undergo tracheal intubation through a video-assisted supraglottic airway device without fiberoptic guidance during general anesthesia.

Device: Video-assisted supraglottic airway device

Conventional Supraglottic Airway Device

ACTIVE COMPARATOR

Participants undergo tracheal intubation through a conventional intubating supraglottic airway device without fiberoptic guidance during general anesthesia.

Device: Conventional intubating supraglottic airway device

Interventions

Video-assisted supraglottic airway device 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.

Also known as: SaCo VLM

Video-assisted Supraglottic Airway Device

Conventional intubating supraglottic airway device 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.

Also known as: AirQ

Conventional Supraglottic Airway Device

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 19 years or older.
• Scheduled to undergo elective surgery under general anesthesia requiring tracheal intubation.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: July 15, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2029
• Last Updated: July 15, 2026

Record last verified: 2026-07