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临床试验/NCT02000674
NCT02000674已完成3 期

Succinylcholine vs Rocuronium for Prehospital Emergency Intubation : a Randomized Trial

Centre Hospitalier Universitaire de la Réunion18 个研究点 分布在 1 个国家目标入组 1,321 人开始时间: 2013年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
1,321
试验地点
18
主要终点
First-pass intubation success rate

研究概览

简要总结

All adult patients with spontaneous cardiac activity and requiring tracheal intubation in the pre hospital emergency context will be included in order to compare the use of succinylcholine vs Rocuronium for prehospital emergency intubation.

详细描述

All adult patients with spontaneous cardiac activity and requiring tracheal intubation in the pre hospital emergency context will be included. All intubation will be performed by an emergency physician or a nurse specialized in anesthesia. For patients with spontaneous cardiac activity, rapid sequence intubation will be performed to allow intubation.

Comparisons studied will be : Intubation success rate at the first laryngoscopy, glottis exposure assessed by Cormack and Lehane classification, difficult intubation rate assessed by the Intubation Difficult Score (IDS), the conditions of intubation assessed by the Copenhagen score, the need for alternative airway techniques and the immediate post intubation complications rate as vomiting, dental trauma, pulmonary inhalation, arterial desaturation , hypotension episodes and cardiac arrest occurrence.

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

入选标准

  • All adult patients with spontaneous cardiac activity and requiring tracheal intubation in the pre hospital emergency context

排除标准

  • Patients in cardiac arrest;
  • Patients under-18s;
  • Patients under guardianship ;
  • Pregnancy known;
  • Patients with cons to one of the following three drugs: rocuronium, succinylcholine, sugammadex;
  • Patients not affiliated to a social security scheme (beneficiary or legal).

研究组 & 干预措施

Administration of Succinylcholine

Active Comparator

Intubation after IV administration of Succinylcholine 1mg/kg

干预措施: Succinylcholine : 1mg/kg (Drug)

Administration of Rocuronium

Experimental

Intubation after IV administration of Rocuronium 1.2 mg/kg

干预措施: Rocuronium : 1.2 mg/kg (Drug)

结局指标

主要结局

First-pass intubation success rate

时间窗: between 1 hour to 3 hours after inclusion

Measured by the proportion of successful intubation in the first laryngoscopy.

次要结局

  • Incidence of difficult intubation(between 1 hour to 3 hours after inclusion)
  • Intubation conditions assessment(between 1 hour to 3 hours after inclusion)
  • Need for alternate airway devices(between 1 hour to 3 hours after inclusion)
  • early intubation-related complications(between 1 hour to 3 hours after inclusion)

研究者

发起方
Centre Hospitalier Universitaire de la Réunion
申办方类型
Other
责任方
Sponsor

研究点 (18)

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