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

N/ANot Yet RecruitingNCT07704723

Seoul National University Hospital204 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

204

Conditions

Airway Management

Interventions

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Intubation time

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

Time frame: During induction of general anesthesia

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

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

Postoperative sore throat

Incidence and severity of postoperative sore throat.

Time frame: 1 hour and 24 hours after surgery

Postoperative hoarseness

Incidence of postoperative hoarseness.

Time frame: 1 hour and 24 hours after surgery