Fiberoptic Bronchoscopy on Supraglottic Airway Devices Position

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Supraglottic Airway Devices Position
• Intervention / Treatment: Device: a native video image system; Device: Fiberoptic bronchoscope

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ICHENG LU; Phone Number: 886-975356677; Email: u9251112@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Third-generation SADs (SaCoVLM); The third-generation SADs (i.e. SaCoVLM™) combines video system and laryngeal mask with gastric drain.	Device: a 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.
Active Comparator: Second-generation SADs (I-gel™); The second-generation SADs (i.e. I-gel™) with a gastric drain conduit have designed to reduce the risk of gastric reflux and aspiration.	Device: a 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.; Device: Fiberoptic bronchoscope; The position of the i-Gel is checked using a fiberoptic endoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
glottic visualization grades by fiberoptic exam assessment	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	From anesthesia induction to the end of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra-operative effectiveness	Secondary outcomes were evaluated by oropharyngeal sealing pressure, first attempt success rate, insertion time	From anesthesia induction to the end of surgery

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 6, 2025
• First Submitted That Met QC Criteria: January 9, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 9, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: fiberoptic bronchoscopy; supraglottic device; video laryngeal mask
• Other Study ID Numbers: KMUHIRB-F(I)-20240331

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: not decided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No