Clinical Performance of the I-gel and the Laryngeal Tube Suction Disposable Supraglottic Airway Devices 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 devices the laryngeal tube suction disposable and the i-gel
研究概览
简要总结
Establishing a definitive airway is 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 Studies revealed that the success rate of tracheal intubation in the prehospital setting is suboptimal.
The Advance Trauma Life Support suggested the use of the Supraglottic Airway Devices in managing patients who require an advanced airway adjunct, but in whom intubation has failed.
The Laryngeal Tube Suction Disposable (LTS-D), was introduced as an alternative for managing the difficult airway, initially intended for routine clinical use.
Within recent years, laryngeal tubes have also been reported to be successfully used in emergency airway management.
The i-gel disposable airway is proposed as a new supraglottic airway device (SAD) made of a medical grade thermoplastic elastomer. Its unique design does not need an inflatable cuff.
A randomized controlled trail will be conducted. Participants will insert the both supraglottic airway devices to compare performance of ventilation and oxygenation of the patients.
The insertion will be performed on aged 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, an size 5 and the LTS-D size 4 and the size 5.
For induction of anesthesia, all patients will receive premedication with oral diazepam (10 mg). After 3 min of preoxygenation with an inspired oxygen fraction of 100%, anesthesia will be induced with up to 3mcg/kg fentanyl and 2-3 mg/kg propofol and will be maintained with 70% nitrous oxide/30% oxygen and sevoflurane. Neuromuscular blockade will be obtained with rocuronium. After complete neuromuscular blockade, the study procedure will be initiated. The participant will perform one insertion of i-gel or the LTS-D on the patient while manual in-line stabilization of the neck.
Primary outcome measure - insertion success rate. The primary outcome measure will be success rate of effective insertion of the Supraglottic Airway Devices in the patients with registration of the CO2 (carbon di oxide) curve.
Secondary outcome measure - duration in seconds of the insertion. The duration of the Supraglottic Airway Devices insertion will be defined as the duration time, in seconds, from insertion of the Supraglottic Airway Devices in the lips of the patient until will be correctly positioned in the trachea by the participant.
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, 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 care providers. The Tactical Combat Casualty Care Guidelines recommend using a supra glottic airway device as an option to assist in securing the airway in tactical evacuation phase of care. The utility of a supraglottic airway device is also recommended by the American College of Surgeons. In a randomized controlled trail in patient, the success of blind intubation did not support the use of tracheal intubation via intubating Laryngeal Tube Suction-Disposable (iLTS-D) by novice intubators. However, this study revealed a high success rate (84.6%) of intubating Laryngeal Tube Suction-Disposable placement in the oropharynx, associated with effective ventilation as confirmed by capnography.
The time to obtain successful iLTS-D placement in the oropharynx was 42 sec, which is 2.5 times shorter than the time to achieve tracheal intubation with Direct Laryngoscopy.
These findings suggest that novice intubators can use a second generation Supraglottic Airway Device as the first airway intervention in trauma patients who require immediate airway management.
The ATLS suggested the use of the Supraglottic Airway Devices (SGAD) in managing patients who require an advanced airway adjunct, but in whom intubation has failed or is unlikely to succeed.
The American Association of Anesthesiology include the use of Supraglottic Airway Device in the control of the airway in cases of difficult intubation Difficult Airway Society 2015 guidelines for management of unanticipated difficult intubation in adults included the use of SGAD in the Guidelines of difficult intubation.
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 Anesthesiologists) guidelines I-II
- •non pregnancy
排除标准
- •Difficult airway
- •Pregnancy
结局指标
主要结局
Insertion success ratio between supraglottic devices the laryngeal tube suction disposable and the i-gel
时间窗: 30 seconds
Comparison of the insertion success in the oropharynx of laryngeal tube suction disposable and the i-gel 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 Professor of Anesthesiology
Bnai Zion Medical Center