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临床试验/NCT02462915
NCT02462915Unknown不适用

A Study Comparing the Supraglottic Airway Devices and Endotracheal Tube During Controlled Ventilation for Laparoscopic Surgery

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
leak fraction

研究概览

简要总结

In our study, we compared the ventilation performance of i-gel to the endotracheal tube during laparoscopic surgery.

The lungs were ventilated at tidal volumes (8mL/kg) using volume controlled. After that, we wanted to observe the respiratory parameters, such as leak fraction, leak volume, tidal volume, peak airway pressure and mean airway pressure.

In our hypothesis, the i-gel may be used reasonable alternative to tracheal tube during volume controlled ventilation in laparoscopic surgeries.

详细描述

In our study, we compared the ventilation performance of i-gel to the endotracheal tube during laparoscopic surgery.

Our patient receive i-gel or endotracheal tube by draw. These patients were Included by the criteria:1.ASA I-II2.Age from 20-80 years old, who were underwent elective GYN laparoscopic surgery and had ability to give inform consent.

The excluding criteria was: 1.presence of any significant lung, heart, brain disease 2. pathology of the neck or upper respiratory tract 3.Potential difficult intubation 4.an increased risk of aspiration, ex:gastroesophageal reflux, full stomach,Obese (BMI>30), and pregnant woman, who were confirmed by patient history and medical chart.

Preoxygenation was maintained for three minutes to avoid bag and mask ventilation. Anesthesia was induced with the routine medication, such as lidocaine、 propofol, fentanyl and cisatracurium. The i-gel or endotracheal tubes were inserted. The lungs were ventilated at the tidal volume (8mL/kg) using volume controlled. After that, we wanted to observe the respiratory parameters, such as leak fraction, leak volume, tidal volume, peak airway pressure and mean airway pressure.

In our hypothesis, the i-gel may be used reasonable alternative to tracheal tube during volume controlled ventilation in laparoscopic surgeries.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • ASA I-II2.Age from 20-80 years old, who were underwent elective GYN laparoscopic surgery and had ability to give inform consent.

排除标准

  • presence of any significant lung, heart, brain disease
  • pathology of the neck or upper respiratory tract
  • Potential difficult intubation
  • an increased risk of aspiration, ex:gastroesophageal reflux, full stomach,
  • Obese (BMI>30),
  • pregnant woman, who were confirmed by patient history and medical chart

研究组 & 干预措施

i-gel, an brand of supraglottic airway device

Experimental

a supraglottic airway devices with a gastric suction channel

干预措施: i-gel (Device)

i-gel, an brand of supraglottic airway device

Experimental

a supraglottic airway devices with a gastric suction channel

干预措施: lidocaine, propofol, fentanyl and cisatracurium (Drug)

endotracheal tube

Experimental

traditional use for protect airway during the surgery

干预措施: endotracheal tube (Device)

endotracheal tube

Experimental

traditional use for protect airway during the surgery

干预措施: lidocaine, propofol, fentanyl and cisatracurium (Drug)

结局指标

主要结局

leak fraction

时间窗: intraoperative

(inspiratory volume-expiratory volume)/inspiratory volume

次要结局

  • leak volume(intraoperative)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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