Comparison of Haemodynamic Effects During Orotracheal Intubation, by Direct or Indirect Laryngoscopy With Airtraq, Controlled, Prospective, Randomized, Simple-blind, Monocentric Study at the Lille University Hospital Specialties Block.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 218
- 试验地点
- 1
- 主要终点
- change from intubation mean blood pressure at 1 min after intubation
研究概览
简要总结
News techniques of intubation by indirect laryngoscopy have arrived in operating rooms but they are still too restricted to situations (difficult intubation criteria ..). It wanted to focus on indirect laryngoscopy by Airtraq. This technique allows better exposure during intubation while limiting mouth opening and cervical hyper extension, but also dental trauma and lip wounds. It also reduces the duration of laryngoscopy and therefore at the same time the apnea time. After a review of the literature, it has been proven that its use reduces haemodynamic changes during intubation. But these studies have been realized only in very particular patients (obese, heart failure) and with induction protocols that are not used routinely in our operating theaters.
Reasons why it decided to carry out this study, on the one hand to find these results and especially to be able to extend them to the whole population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Specific medical conditions: ASA 1 or 2
- •Patient having given written consent to participate in the category 2 trial
- •Intubation realized by experienced person
- •Social Insured Patient
- •Patient willing to comply with all procedures of the study and its duration
排除标准
- •Demographic characteristics: minor, over 65
- •Medical history: history of difficult intubation, hypertension
- •Lille intubation score greater than or equal to 7
- •Treatments in progress: Beta taking blocking the day of the operation.
- •Administrative reasons: inability to receive informed information, inability to participate in the entire study, lack of coverage by the social security system, refusal to sign consent
结局指标
主要结局
change from intubation mean blood pressure at 1 min after intubation
时间窗: between the values before intubation (T0) and 1min after intubation.
次要结局
- Frequency of patients with hemodynamic reaction post intubation (minimal variation of mean blood pressure or heart rate of 20%(between values before intubation and 1, 2, 5, 10 minutes after intubation.)
- Variation of blood pressure (PAM)(between the values before intubation (T0) and 2, 5 and 10 minutes of intubation)
- Frequency of patients with dental trauma and / or an injury to the lips due to the intubation device.(at 10 min after intubation)
- Variation of heart rate (HR)(between the values before intubation (T0) and 1, 2, 5 and 10 minutes of intubation)
- Mean of the arterial blood pressure and heart rate(before intubation and at 1,2,5 and 10 minutes from intubation.)
- instantaneous ANI delta(between ANI before intubation and 1,2,5 and 10 min after intubation)
- Intubation time in seconds from introduction of the intubation device into the mouth with inflation of the balloon(at 1 min after intubation)