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临床试验/NCT03501602
NCT03501602Unknown不适用

Comparison of Endotracheal Intubation Over the Aintree Catheter With Fiberoptic Bronchoskop Via the I-gel and Laryngeal Mask Airway Protector

Kocaeli Derince Education and Research Hospital2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年4月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
2
主要终点
Time to Successful Tracheal Intubation

研究概览

简要总结

Investigators aimed to compare the ease of use of the LMA protector and I-gel LMA for tracheal intubation with the Aintree catheter in our study.

Laryngeal mask airway (LMA) protector is the second generation perilaryngeal seal type supraglottic airway tool. The I-gel LMA is the second generation uncuffed supraglottic airway device. The Aintree Intubation Catheter has been designed for assisted fiberoptic intubation and for uncomplicated, atraumatic endotracheal tube exchange.Both LMA types have a structure that permits endotracheal intubation. In cases of difficult intubation, these two LMA types can be used. In the literature, there is no study comparing these two LMA types using Aintree catheter.Difficult Airway Society (DAS) published a guide for tracheal intubation in 2011 using Aintree. According to this guide, LMA type LMA Supreme is the most unfavorable for this process. However, there is no research or recommendation on the type of LMA most suitable for use in the literature. In accordance with the data of this study, it will be tried to show which LMA type may be suitable for intubation with Aintree catheter in patients.

详细描述

Investigators will include adult patients over 18 years of age who will undergo a surgical operation requiring intubation. Patients will be divided into protector LMA and I-gel LMA groups by closed envelope method. Forty patients are planned for both groups. The age, weight, height, body mass index (BMI) of the patients, operation to be performed, ASA, mallampati, thyromental distance values will be recorded. A standard induction of anesthesia will be applied to the patient. After 2 minutes the LMA will be inserted. It will be recorded how many numbered LMAs are used, success rate, number of trials, optimization maneuver required. With LMA, whether sufficient amount of tidal volume can be given to the patient and whether sufficient amount of chest departure is observed during ventilation will be recorded together with tidal volume values. In patients with adequate ventilation, an Aintree catheter placed on a fiberoptic bronchoscope in LMA will be delivered. Fiberoptic laryngeal appearance staging will be performed:

Stage 4: only the cords look Stage 3: cords + posterior epiglot seen Stage 2: cords + anterior epiglot seen Stage 1: no cords seen Cord vocals will be seen on the monitor and the aintree catheter will be sent into the trachea. After insertion of the trachea, the fiberoptic bronchoscope and LMA are removed and the patient's intubation tube is advanced through the Aintree catheter in the appropriate size and the tube is placed in the trachea. Once participants have made sure that the tube is trachea, it will be removed. The time from insertion of the LMA to placement of the endotracheal tube will be coded. During the procedure, the patient's blood pressure, heart rate, oxygen saturation, any complications that may develop will be recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Be intubated in surgical operation requiring intubation
  • over 18 years old

排除标准

  • Difficult intubation story
  • Difficult intubation risk
  • Presence of gastric reflux

研究组 & 干预措施

LMA protector group

Active Comparator

The LMA Protector is a single use supraglottic airway device. This airway device provides access and functional separation of the respiratory and digestive tracts

干预措施: LMA protector (Device)

I-gel LMA group

Active Comparator

The I-gel is an alternative supraglottic device which provides the seal over the airway versus an inflatable cuff.

干预措施: I-gel LMA (Device)

结局指标

主要结局

Time to Successful Tracheal Intubation

时间窗: Up to 10 minutes

This measure of time begins with the handling of the supraglottic device to confirming the appropriate placement of the device by noting the presences of end tidal carbon dioxide.

次要结局

  • Time to Placement of the Aintree Airway Intubation Catheter(Up to 10 minutes)
  • Time to Placement of the Supra Glottic Device(Up to 10 minutes)
  • Laryngeal appearance staging(Up to 10 minutes)

研究者

发起方
Kocaeli Derince Education and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aslı duygu aydaş

specialist doctor

Kocaeli Derince Education and Research Hospital

研究点 (2)

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