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This study aims to compare the effectiveness of SaCoVLMâ„¢ 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.
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 SaCoVLMâ„¢ 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 SaCoVLMâ„¢ 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 SaCoVLMâ„¢, whether visible blood clots adhere to the device upon removal, changes in vital signs before and after placement, and postoperative adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| the success rate and difficulty of initial placement of the SaCoVLMâ„¢ | One of the secondary outcomes is the success rate and difficulty of initial placement of the SaCoVLMâ„¢. We will record the number of attempts to place or adjust the laryngeal mask to proper position. | From enrollment to postoperative day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Po-Yang Chen, MD | Contact | 886-7-3121101 | 7035 | t38026641102@gmail.com |
| I-Cheng Lu, Ph.D. | Contact | 886-7-3121101 | 7035 | u9251112@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City | Sanmin Dist | 80756 | Taiwan |
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| whether visible blood clots adhere to the device upon removal |
One of the secondary outcomes is 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 | One of the secondary outcomes is 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 | One of the secondary outcomes is changes in mean arterial blood pressure values before and after SaCoVLM placement. | From enrollment to postoperative day 1 |
| postoperative adverse events | 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. | From enrollment to postoperative day 1 |