Optimizing Third-Generation Video Laryngeal Mask Position: SaCoVLM™ vs. Fiberoptic Bronchoscope
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: video image through laryngeal mask specific channel.
- Who it may be relevant to
- Registry conditions: Supraglottic Airway Device. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Optimal Position of the Third Generation Video Laryngeal Mask Airway: to Compare Visualization of the SaCoVLMTM Videoscope With the Traditional Fiberoptic Bronchoscope
Overview
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.
Interventions
- 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
Primary outcome measures
- correlation of native camera image of SaCoVLM and traditional fiberoptic endoscopy image [Time frame: From enrollment to postoperative day 1]
Secondary outcome measures (5)
- the success rate and difficulty of initial placement of the SaCoVLM™ [Time frame: From enrollment to postoperative day 1]
- whether visible blood clots adhere to the device upon removal [Time frame: From enrollment to postoperative day 1]
- changes in heart rate values before and after SaCoVLM placement [Time frame: From enrollment to postoperative day 1]
- changes in mean arterial blood pressure values before and after SaCoVLM placement [Time frame: From enrollment to postoperative day 1]
- postoperative adverse events [Time frame: From enrollment to postoperative day 1]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Taiwan · 1 center
- Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City
Identifiers
NCT: NCT06750926 · KMUHIRB-F(II)-20240241