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临床试验/NCT04951089
NCT04951089Unknown不适用

Comparison of the Clinical Performances of Air-Q SP 3G and i-Gel by Novice Intubators During Manual In-line Neck Stabilization: A Randomized Controlled Trial

Bnai Zion Medical Center0 个研究点目标入组 80 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
主要终点
Insertion success ratio between supraglottic device the i-gel and Air-Q SP 3G Comparison of the insertion success in the oropharynx of the i-gel and the Air-Q SP 3G supraglottic devices, insertion success detected by capnography trace

研究概览

简要总结

Establishing a definitive airway defined as a tube placed in the trachea with cuff inflated below the vocal cords is the first priority in the airway management of the pre-hospital trauma patient, according to the last edition of the Advanced Trauma Life Support (ATLS) textbook, of the American College of Surgeons. However, studies revealed that the success rate of tracheal intubation in the prehospital setting using direct laryngoscopy (DL), the standard intubation technique is suboptimal. The Advance Trauma Life Support suggested the use of Supraglottic Airway Devise (SAD) in managing the difficult airway. The air-Q SP 3G was introduced as an alternative for managing the difficult airway. The i-gel is proposed as supraglottic device made of a medical grade thermoplastic elastomer. The unique design of both devices is that a cuff is not needed to be inflated .

A randomize controlled trail will be conduce. Participants will insert the both supraglottic devices to compare performance of ventilation and oxygenation of the patients.

The insertion will be performed on age 18-75 year patients, scheduled for elective surgery with general anesthesia. The SAD use in the study will be a single use i-gel size 4 or 5 and the air-Q SP 3G- size 4 or 5 For induction of anesthesia all patients will receive premedication. After 3 min of preoxygenation anesthesia will induce with up to 2 mcg/Kg fentanyl and 2-3 mg propofol Neuromuscular blockade will be obtained with rocuronion.

The participant will performed one insertion of the i-gel or the air-Q SP 3G on the patient while manual in-line stabilization of the neck Primary outcome: time to success insertion of SAD Secondary outcome : duration in seconds of insertion

详细描述

In the combat setting, airway compromise is the second leading cause of preventable death after hemorrhage.

Establishing a definitive airway defined as a tube placed in the trachea with cuff inflated below the vocal cords is the first priority in the airway management of the pre-hospital trauma patient, according to the last edition of the Advanced Trauma Life Support (ATLS) textbook, of the American College of Surgeons. However, studies revealed that the success rate of tracheal intubation in the prehospital setting using direct laryngoscopy (DL), the standard intubation technique is suboptimal.

Possible reasons for the failure in achieving definitive airway in trauma patients are the requirement for in-line stabilization of the neck, and the inexperience of the providers.

The Tactical Combat Casualty Care (TCCC) Guidelines recommend using a supraglottic airway device (SAD) as an option to assist in securing the airway in tactical evacuation phase of care.

In a recent published Randomized Control Trail in patients, the success of blind intubation did not support the use of tracheal intubation (TI) via iLTS-D by novice intubators. However, this study revealed a high success rate (84.6%) of iLTS-D placement in the oropharynx, associated with effective ventilation as confirmed by capnography.

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
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient ASA ( American Society Anesthesiologist) I-II
  • non pregnancy

排除标准

  • Difficult airway
  • pregnancy

结局指标

主要结局

Insertion success ratio between supraglottic device the i-gel and Air-Q SP 3G Comparison of the insertion success in the oropharynx of the i-gel and the Air-Q SP 3G supraglottic devices, insertion success detected by capnography trace

时间窗: From insertion of supraglottic between the lips of the subject to final success or failure of insertion 30 seconds

Comparison of the insertion success in the oropharynx of i-gel and the Air-Q SP 3G supraglottic devices, insertion success detected by capnography trace

次要结局

未报告次要终点

研究者

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

LUIS GAITINI MD

Associate Clinical Prpfessor of Anesthesiology

Bnai Zion Medical Center

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