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

Not Applicable

Not yet recruiting

• Conditions: Supraglottic Airway Device

• Registration Number: NCT06750926
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief Summary

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.

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 Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-12-18
• Study First Submitted QC: 2024-12-25
• Last Update Submitted: 2024-12-25
• Study First Posted: 2024-12-27
• Last Update Posted: 2024-12-27
• Study Start: 2025-01-01
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
correlation of native camera image of SaCoVLM and traditional fiberoptic endoscopy image	From enrollment to postoperative day 1	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.

Secondary Outcome Measures

Name	Time	Method
the success rate and difficulty of initial placement of the SaCoVLM™	From enrollment to postoperative day 1	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.
whether visible blood clots adhere to the device upon removal	From enrollment to postoperative day 1	One of the secondary outcomes is whether visible blood clots adhere to the device upon removal.
changes in heart rate values before and after SaCoVLM placement	From enrollment to postoperative day 1	One of the secondary outcomes is changes in heart rate values before and after SaCoVLM placement.
changes in mean arterial blood pressure values before and after SaCoVLM placement	From enrollment to postoperative day 1	One of the secondary outcomes is changes in mean arterial blood pressure values before and after SaCoVLM placement.
postoperative adverse events	From enrollment to postoperative day 1	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.

Trial Locations

Locations (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung, Sanmin Dist, Taiwan