Randomized Controlled Trial Comparing the Efficiency of Three Third Generation Supraglottic Airways as an Intubation Route
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Time for intubation
研究概览
简要总结
A "can't intubate, can't oxygenate" situation is life-threatening and the physician must be prepared to react quickly. Similarly, a difficult intubation with adequate ventilation is associated with complications. In both of these situation and as recommend by different societies, a supra-glottic airway (SGA) device can be used to help ventilation, or as an intubation conduit to ease the airway access. The objective of this randomized controlled trial is to establish which SGA, between the AuraGain, AirQ Blocker and I-Gel, allows the fastest intubation time in an adult population, with the objective of minimizing complications related to these situations. The investigators will conduct a three-arm trial to compare different outcomes related to the installation of the SGA and its use as an intubation conduit. The results of this trial will inform the anesthesiologist on which device to use on to have close in case of airway emergencies.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age >18 years old
- •ASA score of 1-3
- •Elective or urgent surgery planned to last at least 30 minutes under general anesthesia with endotracheal intubation
排除标准
- •Any contraindication to the use of SGA devices considered by the anesthesiologist (Uncontrolled gastro-eosophageal reflux, oropharyngeal pathology or gross deformation, etc.)
- •Any contraindication to the drugs planned by the trial
- •Pregnancy
- •Severe or uncontrolled obstructive pulmonary disease
- •Significant cervical spine anomaly
研究组 & 干预措施
AirQ Blocker supra-glottic airway device
Group of patients in which the Air-Q Blocker will be used and measured as an intubation conduit.
干预措施: Insertion of AirQ Blocker and intubation through the device (Device)
AuraGain supra-glottic airway device
Group of patients in which the AuraGain will be used and measured as an intubation conduit.
干预措施: Insertion of AuraGain and intubation through the device (Device)
I-Gel supra-glottic airway device
Group of patients in which the I-Gel will be used and measured as an intubation conduit.
干预措施: Insertion of I-Gel and intubation through the device (Device)
结局指标
主要结局
Time for intubation
时间窗: Through study completion, an average of half an hour (no follow-up required)
This outcome corresponds to the time required to intubate with endotracheal tube (ET) through the supra-glottic airway device. The timer will be started when the flexible fiberoptic intubation scope is inserted in the SGA, and will be stopped when the air cuff of the ET is inflated inside the trachea and carbon dioxide (CO2) is obtained. This outcome will be assessed by the either the performer or second person responsible for data collection.
次要结局
- Success of intubation on first attempt(Through study completion, an average of half an hour (no follow-up required))
- Success of intubation through the SGA(Through study completion, an average of half an hour (no follow-up required))
- Number of attempts for intubation(Through study completion, an average of half an hour (no follow-up required))
- Time for whole procedure(Through study completion, an average of half an hour (no follow-up required))
- Laryngeal view grades(Through study completion, an average of half an hour (no follow-up required))
- Easiness of insertion and ventilation of the SGA(Through study completion, an average of half an hour (no follow-up required))
- Easiness of intubation(Through study completion, an average of half an hour (no follow-up required))
- Easiness of removal of the SGA after a completed endotracheal intubation(Through study completion, an average of half an hour (no follow-up required))
- Adverse events(Through study completion, an average of half an hour (no follow-up required))
研究者
Marie-Josee Colas
Anesthesiologist
Université de Sherbrooke