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

NCT ID: NCT06750926

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2026-07-31

Brief Summary

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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

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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.

Conditions

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Supraglottic Airway Device

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

video image through laryngeal mask specific channel

Intervention Type 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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Sanmin Dist, Taiwan

Site Status

Countries

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Taiwan

Central Contacts

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Po-Yang Chen, MD

Role: CONTACT

Phone: 886-7-3121101

Email: [email protected]

I-Cheng Lu, Ph.D.

Role: CONTACT

Phone: 886-7-3121101

Email: [email protected]

Facility Contacts

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Kuang-I Cheng Cheng, Phd

Role: primary

Other Identifiers

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KMUHIRB-F(II)-20240241

Identifier Type: -

Identifier Source: org_study_id