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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SaCoVLM™ video laryngeal mask | Active Comparator | SaCoVLM™ video laryngeal mask |
|
| LMA Supreme | Active Comparator | LMA Supreme |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SaCoVLM™ video laryngeal mask | Device | The SaCoVLM™ video laryngeal mask will be placed directly into the hypopharyngeal space until resistance is felt, following the recommended instructions for use. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately after the laryngeal mask is placed, before start of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Intraoperative period after the LMA insertion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Burhan Dost, Assoc. Prof. | Ondokuz Mayıs University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ondokuz Mayis University | Samsun | 55270 | Turkey (TĂĽrkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28870163 | Background | Oba S, Turk HS, Isil CT, Erdogan H, Sayin P, Dokucu AI. Comparison of the Supreme and ProSeal laryngeal mask airways in infants: a prospective randomised clinical study. BMC Anesthesiol. 2017 Sep 5;17(1):125. doi: 10.1186/s12871-017-0418-z. | |
| 28510747 | Background | Van Zundert AAJ, Gatt SP, Kumar CM, Van Zundert TCRV, Pandit JJ. 'Failed supraglottic airway': an algorithm for suboptimally placed supraglottic airway devices based on videolaryngoscopy. Br J Anaesth. 2017 May 1;118(5):645-649. doi: 10.1093/bja/aex093. No abstract available. |
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A block randomization list will be created by a doctor who does not participate in patient follow-up using a web-based program, 'Research Randomizer ('Urbaniak and Plous 2013')'.
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Sealed opaque envelopes containing study participation numbers will be used to assign each patient. A researcher not involved in patient follow-up will use the web-based "Research Randomizer" ('Urbaniak and Plous 2013') tool to give each participation number to a random group with a 1:1 ratio.
A nurse not an active investigator in the study will have each participant choose an envelope containing the study participation number. They will inform the anesthetist who will administer the methods which group the patient is in immediately before administration. Researchers, patients, surgeons, and nurses will not be aware of the randomization of groups.
| LMA Supreme | Device | 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. |
|
| Peak Inspratuar Pressure and Plato Pressure |
Peak Inspratuar Pressure and Plato Pressure will be measured after the OLP measurement |
| Intraoperative period |
| Insertion time | Insertion time will be the time between picking up the device and successful placement | 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. | Intraoperative period |
| Blood pressure | Non-invasive blood pressure will measure blood pressure in millimeters of mercury. | 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. | 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 | 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) | Intraoperative and postoperative day 1. |
| 36138363 | Background | Yan CL, Zhang YQ, Chen Y, Qv ZY, Zuo MZ. Comparison of SaCoVLM video laryngeal mask-guided intubation and i-gel combined with flexible bronchoscopy-guided intubation in airway management during general anesthesia: a non-inferiority study. BMC Anesthesiol. 2022 Sep 22;22(1):302. doi: 10.1186/s12871-022-01843-x. |
| 23318811 | Background | Belena JM, Nunez M, Anta D, Carnero M, Gracia JL, Ayala JL, Alvarez R, Yuste J. Comparison of Laryngeal Mask Airway Supreme and Laryngeal Mask Airway Proseal with respect to oropharyngeal leak pressure during laparoscopic cholecystectomy: a randomised controlled trial. Eur J Anaesthesiol. 2013 Mar;30(3):119-23. doi: 10.1097/EJA.0b013e32835aba6a. |
| 36308611 | Background | Yan CL, Zhang YQ, Chen Y, Qv ZY, Zuo MZ. To compare the influence of blind insertion and up-down optimized glottic exposure manoeuvre on oropharyngeal leak pressure using SaCoVLM video laryngeal mask among patients undergoing general anesthesia. J Clin Monit Comput. 2023 Apr;37(2):593-598. doi: 10.1007/s10877-022-00930-1. Epub 2022 Oct 29. |
| 40610857 | Derived | Ozden GG, Dost B, Kaya C, Turunc E, Koksal E, Ustun YB, Bilgin S, Baris S. Comparison of oropharyngeal leak pressure between the SaCoVLM video laryngeal mask and LMA supreme in adult elective surgery patients: a prospective randomized controlled trial. BMC Anesthesiol. 2025 Jul 3;25(1):334. doi: 10.1186/s12871-025-03218-4. |