SaCoVLM™ Video Laryngeal Mask Versus LMA Supreme
- Conditions
- AirwayAnesthesia
- Interventions
- Device: SaCoVLM™ video laryngeal maskDevice: LMA Supreme
- Registration Number
- NCT06245668
- Lead Sponsor
- Ondokuz Mayıs University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 180
- Age 18-80 years
- BMI < 35 kg/m2
- ASA (American Society of Anesthesiologists) physical score I/II
- Elective surgeries lasting less than 90 minutes
- Patients who are expected to have a difficult airway
- Those with potential risk of regurgitation (severe reflux, presence of hiatal hernia)
- Those who will undergo head and neck surgery, laparoscopic surgery
- Those who will undergo surgery in the prone position
- Emergency surgical interventions
- Those requiring muscle relaxants
- Presence of oral abscess, pharyngeal pathology
- Those who have had an upper or lower respiratory tract infection in the last 4 weeks
- History of allergy to medications used
- Failure to obtain the consent of patients or their families
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SaCoVLM™ video laryngeal mask SaCoVLM™ video laryngeal mask SaCoVLM™ video laryngeal mask LMA Supreme LMA Supreme LMA Supreme
- Primary Outcome Measures
Name Time Method Oropharyngeal leak pressure Immediately after the laryngeal mask is placed, before start of surgery 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.
- Secondary Outcome Measures
Name Time Method Assessment of Glottis Visualization Scores Intraoperative period after the LMA insertion 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.
Peak Inspratuar Pressure and Plato Pressure Intraoperative period Peak Inspratuar Pressure and Plato Pressure will be measured after the OLP measurement
Insertion time 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.) Insertion time will be the time between picking up the device and successful placement
Number of attempts to place the device Intraoperative period Number of attempts needed for successful placement will be recorded.
Blood pressure Preoperatively, one minute after the induction, fifth minute and before removed laryngeal mask. Non-invasive blood pressure will measure blood pressure in millimeters of mercury.
Heart rate Preoperatively, one minute after the induction, fifth minute and before removed laryngeal mask. Heart rate will be measured in beats per minute with an electrocardiography monitor.
Peripheral oxygen saturation Preoperatively, one minute after the induction, fifth minute and before removed laryngeal mask. Peripheral oxygen saturation per minute will be measured by pulse oximetry
Complications Intraoperative and postoperative day 1. 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)
Trial Locations
- Locations (1)
Ondokuz Mayis University
🇹🇷Samsun, Turkey