Our study aimed to compare two different laryngeal masks, SaCoVLM™ Video Laryngeal Mask and blind placement with LMA Supreme, in adult patients undergoing short elective surgeries. The aim is to optimize the use of commonly used laryngeal masks in clinical practice and examine the differences in oropharyngeal leak pressures.
Laryngeal masks are alternative airway devices commonly used in anesthesia, serving both spontaneously breathing and ventilated patients. LMA Supreme, a second-generation laryngeal mask, has been widely used in routine anesthesia practices and short-duration procedures in our clinic. The advantage of second-generation masks is the presence of gastric access pathways, allowing for additional decompression of the stomach. SaCoVLM™ Video Laryngeal Mask also features a gastric access pathway. Placement of laryngeal masks requires attention to the anatomical features of the airway. Unsuccessful placement of a laryngeal mask can lead to issues such as throat pain, hoarseness, difficulty swallowing, airway obstruction, or leakage, as well as an increase in intragastric pressure due to gastric distention. Our research is a prospective, randomized, controlled method study.The aim in this study is to reveal most accurate placement technique and device to transfer this method to clinical applications. Patients will be evaluated in two groups. Group 1: Placement with SaCoVLM™ video laryngeal mask Group 2: Placement of the LMA Supreme with standard technique After LMA Supreme and SaCoVLM™ video laryngeal mask placement, airway sealing pressures will be measured with appropriate technique. Airway tightness pressure measurement will be made with the technique accepted in the literature through the sensors in the anesthesia machine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
180
The SaCoVLM™ video laryngeal mask will be placed directly into the hypopharyngeal space until resistance is felt, following the recommended instructions for use.
The LMA Supreme will be inserted directly by hand and placed into the hypopharyngeal space until resistance is felt, as per the recommended instructions for use.
Ondokuz Mayis University
Samsun, Turkey (Türkiye)
Oropharyngeal leak pressure
Oropharyngeal leak pressure (OLP) will be measured by closing the adjustable pressure limiting valve on the anesthesia machine. The fresh gas flow was adjusted to 4 L/min. When the APL (Adjustable pressure limiting) valve was closed and manually ventilated. The leak sound that occurs during ventilation will be auscultated. The first peak airway pressure at which the leak occurs will be recorded as the oropharyngeal leak pressure. After successful insertion, laryngeal mask location will be evaluated with fiberoptic imaging.
Time frame: Immediately after the laryngeal mask is placed, before start of surgery
Assessment of Glottis Visualization Scores
This will be assessed using five stages; Stage 1: Vocal cords not visible. Stage 2: Vocal cords and anterior epiglottis visible. Stage 3: Vocal cords and posterior epiglottis visible. Stage 4: Only vocal cords visible.
Time frame: Intraoperative period after the LMA insertion
Peak Inspratuar Pressure and Plato Pressure
Peak Inspratuar Pressure and Plato Pressure will be measured after the OLP measurement
Time frame: Intraoperative period
Insertion time
Insertion time will be the time between picking up the device and successful placement
Time frame: Procedure (Time from LMA handling to first wave formation in capnography, assessed from the initiation of LMA handling until the detection of the first capnography wave.)
Number of attempts to place the device
Number of attempts needed for successful placement will be recorded.
Time frame: Intraoperative period
Blood pressure
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Non-invasive blood pressure will measure blood pressure in millimeters of mercury.
Time frame: Preoperatively, one minute after the induction, fifth minute and before removed laryngeal mask.
Heart rate
Heart rate will be measured in beats per minute with an electrocardiography monitor.
Time frame: Preoperatively, one minute after the induction, fifth minute and before removed laryngeal mask.
Peripheral oxygen saturation
Peripheral oxygen saturation per minute will be measured by pulse oximetry
Time frame: Preoperatively, one minute after the induction, fifth minute and before removed laryngeal mask.
Complications
The presence of complications that may be encountered after LMA removal will be investigated (Cough, Bucking, Laryngospasm, Aspiration, Desaturation(SpO2%\< 90%), Need airway assist device(Nasal or oral airway), Blood on the surface of the cuff, hoarseness,sore throat)
Time frame: Intraoperative and postoperative day 1.