Optimizing Third-Generation Video Laryngeal Mask Position: SaCoVLM™ vs. Fiberoptic Bronchoscope

Optimal Position of the Third Generation Video Laryngeal Mask Airway: to Compare Visualization of the SaCoVLMTM Videoscope With the Traditional Fiberoptic Bronchoscope

This study aims to compare the effectiveness of SaCoVLM™ in artificial airway ventilation during general anesthesia, focusing on the correlation between native video camera imaging and fiberoptic endoscopy. Primary outcomes include the analysis of imaging correlation, while secondary outcomes assess initial placement success rates, difficulty, blood clot adherence, vital sign changes, and postoperative complications.

Study Overview

• Status: Not yet recruiting
• Conditions: Supraglottic Airway Device
• Intervention / Treatment: Diagnostic test: video image through laryngeal mask specific channel

Detailed Description

In modern medicine, the management of artificial airways is a crucial component of patient care in emergency departments, operating rooms, and intensive care units, where it plays a vital role in providing respiratory ventilation. The laryngeal mask airway (LMA) is a type of supraglottic airway device. Due to its ease of placement and improvements in ventilation seal and overall angle design, it is now widely used in various clinical situations and can even replace some functions of endotracheal intubation.

However, despite the LMA's ease of placement, operators with limited experience often struggle to adjust it to the optimal position, significantly impacting ventilation effectiveness. Traditionally, to confirm the correct placement of the LMA, practitioners rely on both experiential physical examinations and objective data such as capnography waveforms, leak pressure measurements, ultrasound, and fiberoptic endoscopy images.

The SaCoVLM™ video laryngeal mask is a third-generation supraglottic device that integrates an imaging system, allowing for real-time lateral video recording during placement to observe the relative position of the LMA tip with respect to the vocal cords and surrounding structures.

The aim of this study is to compare the use of SaCoVLM™ for artificial airway ventilation during routine surgical general anesthesia, specifically evaluating the placement adjustments using two different imaging perspectives: the native video camera and fiberoptic endoscopy. The primary outcome is the analysis of the correlation between the two types of imaging. Secondary outcomes include the success rate and difficulty of initial placement of the SaCoVLM™, whether visible blood clots adhere to the device upon removal, changes in vital signs before and after placement, and postoperative adverse events.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Po-Yang Chen, MD; Phone Number: 7035 886-7-3121101; Email: t38026641102@gmail.com
• Study Contact Backup: Name: I-Cheng Lu, Ph.D.; Phone Number: 7035 886-7-3121101; Email: u9251112@gmail.com

Study Locations

• Taiwan
  • Sanmin Dist
    • Kaohsiung, Sanmin Dist, Taiwan, 80756
      • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Contact: Kuang-I Cheng Cheng, Phd; Phone Number: 7035 886-7-3121101; Email: kuaich@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

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: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patients placed SaCoVLM checked position by real-time video image; patients placed SaCoVLM checked position by real-time video image, including native camera and fiberoptic endoscopy	Diagnostic test: video image through laryngeal mask specific channel; patients placed SaCoVLM will be checked the proper position of placement by native camera through specific video channel and fiberoptic endoscopy through ventilation channel perspectively

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
correlation of native camera image of SaCoVLM and traditional fiberoptic endoscopy image	The primary outcome is the analysis of the correlation between the two types of imaging, native camera image of SaCoVLM and traditional fiberoptic endoscopy image, to confirm proper position of laryngeal mask placement.	From enrollment to postoperative day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the success rate and difficulty of initial placement of the SaCoVLM™	One of the secondary outcomes is the success rate and difficulty of initial placement of the SaCoVLM™. We will record the number of attempts to place or adjust the laryngeal mask to proper position.	From enrollment to postoperative day 1
whether visible blood clots adhere to the device upon removal	One of the secondary outcomes is whether visible blood clots adhere to the device upon removal.	From enrollment to postoperative day 1
changes in heart rate values before and after SaCoVLM placement	One of the secondary outcomes is changes in heart rate values before and after SaCoVLM placement.	From enrollment to postoperative day 1
changes in mean arterial blood pressure values before and after SaCoVLM placement	One of the secondary outcomes is changes in mean arterial blood pressure values before and after SaCoVLM placement.	From enrollment to postoperative day 1
postoperative adverse events	One of the secondary outcomes is postoperative adverse events such as sore throat, pain on swallowing, hoarseness, numbness of the tongue, or jaw pain. We will record all the events above along with their severity.	From enrollment to postoperative day 1

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: December 18, 2024
• First Submitted That Met QC Criteria: December 25, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 25, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: KMUHIRB-F(II)-20240241

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No