Comparison of the Airway Sealing Pressures for Three Different Placement Techniques When Using Lma Proseal in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 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 the manual placement, direct laryngoscopy and video laryngoscopy assisted placement techniques of LMA Proseal, a new generation laryngeal mask (LMA), and to find an effective placement technique that does not allow airway leakage in one go.
详细描述
LMA is an airway device frequently used in pediatric anesthesia. It is preferred for short interventions because it is less invasive compared to intubation. However, problems such as not being fully seated, slipping, and leakage can be encountered during placement. Multiple attempts after unsuccessful placement may cause undesirable results such as edema and sore throat. The aim in this study is to reveal the most accurate placement technique and to transfer this method to clinical applications.
Our research is a prospective, randomized controlled method study.
Patients will be divided into 3 groups.
Group 1:(Standard technique)
Group 2:(Placement with direct laryngoscopy)
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 1:1:1 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
- 1 Year 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1-10 years old
- •Between 5-40 kg
- •ASA (American Society of Anesthesiologists) physical score I/II
- •Cases undergoing elective surgery lasting less than 90 minutes
排除标准
- •Patients who are expected to have a difficult airway
- •Those with potential regurgitation risk (severe GER, 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 who need muscle relaxants
- •Presence of intraoral abscess, pharyngeal pathology
- •Those who have had an upper or lower respiratory tract infection in the last 4 weeks
- •History of allergy to the drugs to be used
- •Failure of patients and their relatives to give consent
结局指标
主要结局
Oropharyngeal leak pressure
时间窗: within 2-3 minutes after laryngeal mask insertion 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 3 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, lma proseal location will be evaluated with fiberoptic imaging.
次要结局
- Need for optimization maneuvers(intraoperative period)
- Blood pressure(Preoperatively, one minute after the induction, fifth minute and before removed laryngeal mask.)
- İnsertion time(intraoperative period)
- Number of placement attempts(intraoperative period)
- Peripheral oxygen saturation(Preoperatively, one minute after the induction, fifth minute and before removed laryngeal mask.)
- Complications(intraoperative and postoperative day 1.)
- Heart rate(Preoperatively, one minute after the induction, fifth minute and before removed laryngeal mask.)
研究者
Yasemin Burcu Ustun
Prof.Dr
Ondokuz Mayıs University