A Prospective Randomized Comparative Study Between the Self-pressurized Air-Q With Blocker and Air-Q Blocker in Low Risk Female Patients Undergoing Ambulatory Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Oropharyngeal leak pressure
研究概览
简要总结
In this study investigators shall compare between the two types of air-Q 's; the Air-Q ILA blocker and the Air-Q SP with blocker , regarding good sealing and oropharyngeal leak pressure
详细描述
The Air-Q family has introduced many improved designs, among which the Air- Q blocker intubating laryngeal airway (Air-Q ILA blocker) in 2011. It has all the previously mentioned advantages, and in addition, a new, built-in, soft guide channel that accepts regular Nasal Gastric (NG) tubes to suction or optional Blocker Tubes for accessing the posterior pharynx and managing the esophagus. investigators can suction the pharynx or suction, vent and block the upper esophagus. Ever since the idea of SAD has launched and applying an optimum intra-cuff pressure that maintains enough sealing and at the same time not injurious to the oropharyngeal mucosa concerns anesthesiologists A good seal will provide good ventilation, will guarantee the desired depth of anesthesia at lower gas flows and with lesser leaks to the esophagus, it will not cause rise in intragastric pressure thus preventing regurgitation However When the cuff pressure is more than the mucosal perfusion pressure, it is likely to either cause postoperative pharyngo-laryngeal symptoms (sore throat, dysphagia, dysphonia) or cause local mucosal trauma and nerve injuries Therefore, in 2013 another improvised design of the Air-Q family has evolved, a Self-pressurized Air Q (air-Q SP) with blocker) . It has a drain tube through which a suction tube is passed like the Air-QILA blocker , And Instead of the pilot balloon and inflating cuff, the air-Q SP with blocker incorporates a self-regulating periglottic cuff at the end of this tube, a communication orifice at the junction of the peri-glottic cuff and the airway tube. This communication between two spaces enables the cuff to dynamically regulate intra-cuff pressure depending on airway pressure. This distinguishing feature of the air-Q SP may result in reduced risk for airway morbidities related to cuff hyperinflation. In this study investigators shall compare between the two types of air-Q 's; the Air-Q ILA blocker and the Air-Q SP with blocker , regarding good sealing and oropharyngeal leak pressure
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
- Double (Participant, Investigator)
盲法说明
An online randomization program (http://www.randomizer.org) will be used to generate random list and to allocate patients into the study groups. Random allocation numbers will be concealed in opaque closed envelops. The patient and investigator assessing study outcomes will all be blinded to the study groups allocation.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female patients between the age group of 18 and 50 years.
- •Patients of American Society of Anaesthesiologists (ASA) class I and II.
- •Patients with Ganzouri airway score less than 4.
排除标准
- •ASA III - V patients.
- •Airway score ≥ 4 according to El-Ganzouri Airway Scoring System.
- •Patients with any oropharyngeal pathology.
- •Patients known to have risk of gastric aspiration, gastro-esophageal reflux disease, hiatus hernia or previous upper gastrointestinal tract surgery
结局指标
主要结局
Oropharyngeal leak pressure
时间窗: 10 Minutes after initial assessment
The Oropharyngeal leak pressure after insertion and fixation of the device
次要结局
- Insertion time(10 Minutes)
- Complications associated(24 hours)
研究者
Ahmed Abdalla
Professor of Anesthesia &I.C.U and Pain Clinic, Cairo University
Cairo University