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

NCT06750926 | Not Yet Recruiting DMC

• 1 other identifier: KMUHIRB-F(II)-20240241
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Supraglottic Airway Device

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (1)

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

Diagnostic Test: video image through laryngeal mask specific channel

Interventions

video image through laryngeal mask specific channel DIAGNOSTIC_TEST

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

patients placed SaCoVLM checked position by real-time video image

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Sanmin Dist, 80756, Taiwan

Location

Central Study Contacts

Po-Yang Chen, MD

CONTACT

886-7-3121101; t38026641102@gmail.com

I-Cheng Lu, Ph.D.

CONTACT

886-7-3121101; u9251112@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 27, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: December 27, 2024

Record last verified: 2024-09

Locations

TW (1)