Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06775184

Fiberoptic Bronchoscopy on Supraglottic Airway Devices Position

A comparison of SaCo VLMTM video laryngeal mask airway with the I-gel supraglottic airway during airway management in patients undergoing elective surgery.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Supraglottic Airway Devices Position

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The position of the supraglottic airway is checked using a fiberoptic endoscope: The bronchoscope is placed at the opening of the laryngeal mask, and assessed using the following grading system: Grade 1: Vocal cords not visible. Grade 2: Vocal cords and anterior epiglottis visible. Grade 3: Vocal cords and posterior epiglottis visible. Grade 4: Only vocal cords visible.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ASA classification I~III, age 18~65 y/o, BMI 18~30kg/m2, elective surgery, surgery duration < 2 hours, supine position, general anesthesia with laryngeal mask airway insertion

Exclusion criteria

  • Smoking, betel nuts use, any known anatomical variation or disease of facial or airway structure, anticipated difficult airway, limited mouth opening distance or neck motility, loosening teeth, gastroesophageal reflux history, ongoing upper airway infection or inflammation symptoms

Treatment and study plan

a native video image system

Device

The visualization of the glottic structures through the SaCoVLM™ imaging system is graded as follows: Grade1: Visibility of the lateral portion of the right epiglottic fold and part of the laryngeal inlet. Grade 2: Visibility of both epiglottic folds and part of the laryngeal inlet. Grade 3: Visibility of the laryngeal inlet and part of the vocal cords. Grade 4: Visibility of the entire vocal cords.

Fiberoptic bronchoscope

Device

The position of the i-Gel is checked using a fiberoptic endoscope

Primary outcomes

  1. glottic visualization grades by fiberoptic exam assessment

    Time frame: From anesthesia induction to the end of surgery

    Grade 1: vocal cords were not visualizedGrade 2: vocal cords and anterior epiglottis were visualizedGrade 3: vocal cords and posterior epiglottis were visualized Grade 4: vocal cords only were visualized

Secondary outcomes

  1. Intra-operative effectiveness

    Time frame: From anesthesia induction to the end of surgery

    Secondary outcomes were evaluated by oropharyngeal sealing pressure, first attempt success rate, insertion time

Study contacts

Contact information is provided by the study sponsor or research team.

ICHENG LU

CONTACT

[email protected]

886-975356677

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Registry information

Official study title

The Effect of Fiberoptic Bronchoscopy Examination on Supraglottic Airway Devices Position in Patients Undergoing Elective Surgery

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 15, 2025
Registry last updated
Jan 15, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.