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
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
- 是
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
LUIS GAITINI MD
Associate Clinical Prpfessor of Anesthesiology
Bnai Zion Medical Center
