Menu
Not yet recruiting NCT07704723

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

No phase Interventional Airway Management

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Video-assisted supraglottic airway device, Conventional intubating supraglottic airway device.
Who it may be relevant to
Registry conditions: Airway Management. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • 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]
Secondary outcome measures (5)
  • Intubation time [Time frame: During induction of general anesthesia]
  • Number of intubation attempts [Time frame: During induction of general anesthesia]
  • Overall intubation success rate [Time frame: During induction of general anesthesia]
  • Postoperative sore throat [Time frame: 1 hour and 24 hours after surgery]
  • Postoperative hoarseness [Time frame: 1 hour and 24 hours after surgery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07704723 · 2605-119-1747

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗