跳至主要内容
临床试验/NCT03798392
NCT03798392Unknown不适用

A Randomized Comparison of Self-pressurized Air-Q With Blocker With Baska Mask Supraglottic Airway in Low Risk Female Patients Undergoing Ambulatory Surgery.

Cairo University2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2019年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
62
试验地点
2
主要终点
airway seal pressure 10 minutes after insertion

研究概览

简要总结

Supraglottic airway devices (SGAs) are very commonly used during anesthesia but structural vulnerability to airway morbidity and issues about cuff pressure still concern anesthesiologists. There have been controversial results regarding optimal intra-cuff pressure in various types of cuffed supraglottic airways. When the supraglottic cuff pressure is more than the mucosal perfusion pressure, it is likely to either cause postoperative pharyngo-laryngeal symptoms like sore throat (dysphagia, dysphonia) or cause local mucosal trauma and nerve injuries. Supraglottic airway devices with non-inflatable cuff have advantages in omitting the cuff pressure monitoring and reducing potential pharyngo-laryngeal complications.

Self-pressurizing Air Q blocker is the latest version. It has a drain tube through which a suction tube is passed. There is an inflatable cuff at the end of this tube. On inflation, the cuff seals the esophageal opening into the stomach, preventing any regurgitation of stomach contents. Instead of the pilot balloon and inflating cuff, the air-Q SP with blocker has a communication orifice at the junction of the peri-glotic 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.

The Baska mask is a novel supraglottic airway device with a non-inflatable cuff, an oesophageal drainage inlet and side channels to facilitate aspiration of gastric contents, and an integrated bite-block. It was revealed that the baska mask is relatively easy to insert, provided a high-quality seal with the glotic aperture and the incidence of throat discomfort appeared low.

To our knowledge, and after searching in previous literature, no previous studies have compared the Air-Q SP with blocker with Baska mask; another supraglottic airway devices with non-inflatable cuff.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patients between the age group of 18 and 50 years,
  • ASA class I and II,
  • undergoing elective surgeries,
  • 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 respiratory or pharyngeal pathology.
  • Patients allergic to any drugs in the protocol.
  • Obese patients with body mass index ≥
  • 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

airway seal pressure 10 minutes after insertion

时间窗: 10 minutes after the device insertion.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Abeer Ahmed, MD

Assistant Professor of Anesthesia, SICU and pain management - kasr Aiainy Faculty of Medicine - Cairo University

Cairo University

研究点 (2)

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