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Clinical Trials/NCT06750926
NCT06750926Not yet recruitingNot Applicable

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

Kaohsiung Medical University Chung-Ho Memorial Hospital1 site in 1 country40 target enrollmentStarted: January 1, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
40
Locations
1
Primary Endpoint
correlation of native camera image of SaCoVLM and traditional fiberoptic endoscopy image

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

patients placed SaCoVLM checked position by real-time video image

Experimental

patients placed SaCoVLM checked position by real-time video image, including native camera and fiberoptic endoscopy

Intervention: video image through laryngeal mask specific channel (Diagnostic Test)

Outcomes

Primary Outcomes

correlation of native camera image of SaCoVLM and traditional fiberoptic endoscopy image

Time Frame: 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 Outcomes

  • the success rate and difficulty of initial placement of the SaCoVLM™(From enrollment to postoperative day 1)
  • 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(From enrollment to postoperative day 1)
  • changes in mean arterial blood pressure values before and after SaCoVLM placement(From enrollment to postoperative day 1)
  • postoperative adverse events(From enrollment to postoperative day 1)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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