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临床试验/CTRI/2024/07/071010
CTRI/2024/07/071010尚未招募2/3 期

Comparative study of two different methods of I-gel insertion:Reverse versus Standard technique.

Government of Gujarat1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年7月23日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
入组人数
100
试验地点
1
主要终点
To compare the First attempt insertion success rate

研究概览

简要总结

Supraglottic airway devices (SAD’s ) offers an excellent non invasive option for ventilation in patients undergoing various surgeries and in pre hospital emergencies. They also help in providing a rescue access in patients with difficult intubation.I-gel is a second generation SAD that features a non inflatable anatomically shaped cuff which provides a acceptable airway seal. It has some advantages over endotracheal intubation, such as quick and ease of placement, devoid hemodynamic response of laryngoscopy, lesser requirement for neuromuscular blockade and a lower incidence of postoperative morbidity like laryngospasm, cough at removal, dysphagia, dysphonia . I-gel is conventionally placed with its concave curvature facing the mandible like the LMA. But the bulky design of the I-gel may be hindered by the tongue size while insertion through conventional technique thereby obstructing its passage to the pharynx. This tends to longer time and increasing number of attempts for insertion of I-gel.This study is designed to compare the efficacies of two insertion techniques Standard vs Reverse technique for I-gel placement in terms of success rate ,insertion time and incidence of post op complications.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant 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

  • 1.Planned surgeries of either sex of duration of up to 2 hrs 2.Patients aged 18 to 60 years 3.ASA Grade I, II, 4.Scheduled for surgeries under general anaesthesia with duration of up to 2 hour.
  • 5.Modified mallampatti airway grade I and II.

排除标准

  • 1.Patients taken for emergency surgeries.
  • 2.Patients of any pathology of neck, upper respiratory tract or upper alimentary tract 3.ASA grade III,IV 4.Patients with mouth opening less than 2.5 cm 5.Patients with history of obstructive sleep apnea, pregnancy, hepatic, cardiac, renal abnormality, alcoholism, smokers, diabetes, significant GERD, Obesity, thoracic,Neuro and Cardiac surgeries, Surgery in prone position.

结局指标

主要结局

To compare the First attempt insertion success rate

时间窗: Till successful insertion of I-gel and starting of mechanical ventilation .

in standard method of i-gel insertion and reverse rotational method of i- gel insertion

时间窗: Till successful insertion of I-gel and starting of mechanical ventilation .

次要结局

  • To compare the Number of attempts for successful insertion, Number of manipulations required for successful insertion, hemodynamic changes occurring post insertion and Post operative complications

研究者

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

Dr Sharan V

B.J.Medical college and Civil Hospital ,Ahmedabad

研究点 (1)

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