The Comparison of SaCoVLM™ Video Laryngeal Mask and LMA Supreme in Terms of Oropharyngeal Leak Pressure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Oropharyngeal leak pressure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years
- •BMI < 35 kg/m2
- •ASA (American Society of Anesthesiologists) physical score I/II
- •Elective surgeries lasting less than 90 minutes
排除标准
- •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
结局指标
主要结局
Oropharyngeal leak pressure
时间窗: 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.
次要结局
- Assessment of Glottis Visualization Scores(Intraoperative period after the LMA insertion)
- Peak Inspratuar Pressure and Plato Pressure(Intraoperative period)
- 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.))
- Number of attempts to place the device(Intraoperative period)
- Blood pressure(Preoperatively, one minute after the induction, fifth minute and before removed laryngeal mask.)
- Heart rate(Preoperatively, one minute after the induction, fifth minute and before removed laryngeal mask.)
- Peripheral oxygen saturation(Preoperatively, one minute after the induction, fifth minute and before removed laryngeal mask.)
- Complications(Intraoperative and postoperative day 1.)
研究者
BURHAN DOST
Assoc. Prof. Dr
Ondokuz Mayıs University