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临床试验/CTRI/2026/01/100405
CTRI/2026/01/100405尚未招募不适用

Evaluation of first pass success rate of intubation through i-gel Plus in anesthetized patients without anticipated difficult airway

Kasturba Medical College1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2026年1月19日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
62
试验地点
1

研究概览

简要总结

Effective airway management is a cornerstone of anaesthesia, with successful intubation on the first attempt being associated with reduced complications such as hypoxia, trauma and haemodynamic stability. Recently, supraglottic airway devices (SGADs) with a conduit for tracheal intubation are gaining popularity as a bridge between ventilation and intubation in all patient populations. Furthermore, endotracheal intubation using SGAD is a widely investigated and accepted technique that has been recognised on the emergency pathway of the American Society of Anaesthesiologists’ Difficult Airway Algorithm.The i-gel Plus (Intersurgical Ltd) is an improved version of i-gel with additional features incorporated in the device, such as a supplementary oxygen port for the administration of passive oxygenation as a component of cardiocerebral resuscitation (CCR), a larger gastric channel, an intubation ramp and a longer non-inflatable cuff tip for improving oropharyngeal leak pressure.The intubation ramp provided in the bowl of the non-inflatable cuff helps to ensure an optimal angle of the tracheal tube as it exits the device, allowing reliable and safe passage through the vocal cords into the trachea. Direct laryngoscopy and intubation can induce sympathetic stimulation and potential haemodynamic responses like hypertension and tachycardia. This negative physiological response can be mitigated by intubation through a supraglottic device such as the i-gel plus. However, the clinical performance of i-gel plus is underexplored. Recently, a cadaveric study demonstrated that i-gel plus acts as a superior conduit for fibreoptic intubation than standard i-gel. Its performance as an intubation conduit has not been studied in patients. Hence, we plan to evaluate the safety, feasibility and first pass success rate of endotracheal intubation through i-gel plus

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients of age between 18 to 60 years Patients with American Society of Anesthesiologists physical status I and II requiring general anesthesia with endotracheal intubation.

排除标准

  • Patient refusal Patients with predictors of difficult bag and mask ventilation Patients with predictors of difficult supraglottic airway device placement Patients with predictors of difficult laryngoscopy Patients with an anticipated difficult airway with a Wilson score more than 5 as assessed in preoperative airway examination Patients with increased risk of aspiration, such as morbid obesity and pregnancy Patients with body mass index BMI more than 30 Patients with obstructive airway pathology and reactive airway disease Patients undergoing airway surgeries.

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Shweta Sinha

Manipal Academy of Higher Education

研究点 (1)

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