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NCT Number: NCT07704723

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

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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Key information

Conditions

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: SaCo VLM

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.

Other names: AirQ

Primary outcomes

  1. First-attempt success rate of tracheal intubation through the supraglottic airway device

    Time frame: 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

  1. Intubation time

    Time frame: During induction of general anesthesia

    Time required for tracheal intubation through the assigned supraglottic airway device.

  2. Number of intubation attempts

    Time frame: During induction of general anesthesia

    Number of attempts required to achieve successful tracheal intubation through the assigned supraglottic airway device.

  3. Overall intubation success rate

    Time frame: During induction of general anesthesia

    Proportion of participants with successful tracheal intubation through the assigned supraglottic airway device regardless of the number of attempts.

  4. Postoperative sore throat

    Time frame: 1 hour and 24 hours after surgery

    Incidence and severity of postoperative sore throat.

  5. Postoperative hoarseness

    Time frame: 1 hour and 24 hours after surgery

    Incidence of postoperative hoarseness.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jul 15, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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