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Fiberoptic Bronchoscopy on Supraglottic Airway Devices Position

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06775184
Enrollment
80
Registered
2025-01-15
Start date
2025-02-28
Completion date
2026-12-31
Last updated
2025-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Supraglottic Airway Devices Position

Keywords

supraglottic device, video laryngeal mask, fiberoptic bronchoscopy

Brief summary

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

Detailed description

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.

Interventions

DEVICEa native video image system

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.

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

Sponsors

Kaohsiung Medical University Chung-Ho Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
glottic visualization grades by fiberoptic exam assessmentFrom anesthesia induction to the end of surgeryGrade 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

MeasureTime frameDescription
Intra-operative effectivenessFrom anesthesia induction to the end of surgerySecondary outcomes were evaluated by oropharyngeal sealing pressure, first attempt success rate, insertion time

Contacts

Primary ContactICHENG LU
u9251112@gmail.com886-975356677

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026