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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorSeoul National University Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

204 Participants
are divided into 2 treatment groups
Group A: Video-assisted Supraglottic Airway DeviceExperimental treatment 1 intervention
Group B: Conventional Supraglottic Airway DeviceActive comparator 1 intervention

Trial outcomes

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.

Time frame
At the time of tracheal intubation during induction of general anesthesia

Secondary outcomes

1

Intubation time

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

Time frame
During induction of general anesthesia
2

Number of intubation attempts

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

Time frame
During induction of general anesthesia
3

Overall intubation success rate

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

Time frame
During induction of general anesthesia
4

Postoperative sore throat

Incidence and severity of postoperative sore throat.

Time frame
1 hour and 24 hours after surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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