Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Sanmin Dist, 80756, Taiwan
NCT Number: NCT06750926
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.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Not applicable
Kaohsiung City, Sanmin Dist, 80756, Taiwan
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
Time frame: From enrollment to postoperative day 1
One of the secondary outcomes is the success rate and difficulty of initial placement of the SaCoVLM™. We will record the number of attempts to place or adjust the laryngeal mask to proper position.
Time frame: From enrollment to postoperative day 1
One of the secondary outcomes is whether visible blood clots adhere to the device upon removal.
Time frame: From enrollment to postoperative day 1
One of the secondary outcomes is changes in heart rate values before and after SaCoVLM placement.
Time frame: From enrollment to postoperative day 1
One of the secondary outcomes is changes in mean arterial blood pressure values before and after SaCoVLM placement.
Time frame: From enrollment to postoperative day 1
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.
Contact information is provided by the study sponsor or research team.
Kaohsiung Medical University Chung-Ho Memorial Hospital
Other
Optimal Position of the Third Generation Video Laryngeal Mask Airway: to Compare Visualization of the SaCoVLMTM Videoscope With the Traditional Fiberoptic Bronchoscope
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07196696
Supraglottic Airway Device
Hangzhou, Zhejiang, China
View Trial DetailsNCT05783128
Airway Management, Craniomandibular Disorders
Athens, Greece
View Trial DetailsNCT05201339
Airway Complication of Anesthesia, Intubation; Difficult or Failed
Seoul, South Korea
View Trial DetailsNCT06058481
Supraglottic Airway Device
Cheras, Kuala Lumpur, Malaysia
View Trial Details