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临床试验/NCT01486407
NCT01486407
终止
不适用

An Observational Study of Intubating Conditions Comparing Intraosseous Vascular Access With Peripheral Intravenous Access for Drug Delivery in Rapid Sequence Intubation

Vidacare Corporation2 个研究点 分布在 1 个国家目标入组 4 人2012年2月1日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Airway Control
发起方
Vidacare Corporation
入组人数
4
试验地点
2
主要终点
Time From First Drug Delivery to Operator-perceived Sufficient Relaxation to Perform Endotracheal Tube Placement
状态
终止
最后更新
3个月前

概览

简要总结

This study will evaluate using intraosseous vascular access and intravenous vascular access to give patients the necessary medications to perform rapid sequence intubation, for patients with airway difficulties. The investigators think the device operator will find the intraosseous and intravenous routes equal for drug delivery.

详细描述

This observational study will evaluate the intubating conditions of patients receiving rapid sequence intubation when receiving paralytic drug delivery via intravenous or intraosseous vascular access from the perspective of the medical professional performing rapid sequence intubation. The investigators believe that medical professionals will find equal intubating conditions for intravenous and intraosseous drug delivery.

注册库
clinicaltrials.gov
开始日期
2012年2月1日
结束日期
2012年12月1日
最后更新
3个月前
研究类型
Observational
性别
All

研究者

发起方
Vidacare Corporation
责任方
Sponsor

入排标准

入选标准

  • Requires rapid sequence intubation
  • Succinylcholine is chosen paralytic agent
  • Intravenous (IV) or Intraosseous (IO) access has been established for rapid sequence intubation
  • For IV access patients, their rapid sequence intubation case is the next occurring IV rapid sequence intubation case following an enrolled IO Rapid Sequence Intubation (RSI) case.

排除标准

  • Vascular access other than IV or IO has been established

结局指标

主要结局

Time From First Drug Delivery to Operator-perceived Sufficient Relaxation to Perform Endotracheal Tube Placement

时间窗: during rapid sequence intubation procedure, average expected time frame 30 minutes

Time measured in seconds from first drug delivery to the time of operator-perceived sufficient relaxation to perform endotracheal tube placement

Intubation Difficulty Scale

时间窗: during rapid sequence intubation procedure, average expected time frame 30 minutes

Intubation Difficulty Scale (IDS) provides a numerical Total score describing the difficulty of the intubation procedure based upon the summation of the following individual sub-scores: number of attempts (each additional attempt adds (+)1 point, minimum score=0, no maximum), number of operators (each additional +1 point, minimum score=0, no maximum), use of alternative techniques (each alternative technique +1 point, minimum score=0, no maximum), cormack grade for first oral attempt (measures the quality of the view of the larynx using grades 1 - 4 where higher number means poorer visibility; successful blind intubation=0. minimum score=0, maximum=4), lifting force required (normal=0 or increased=1), laryngeal pressure (not applied=0 or applied=1), vocal cord mobility (abduction=0 or adduction=1). Total IDS minimum score=0, no maximum score. Score 0=Easy; Score 1 - 5 =slight difficulty; Score \>5 =moderate to major difficulty Score infinite =Failed/Impossible intubation

Operator Satisfaction With Intubating Conditions Using Visual Analog Scale

时间窗: during rapid sequence intubation procedure, average expected time frame 30 minutes

Operator reported level of satisfaction with intubating conditions regarding adequacy of sedation and adequacy of muscular relaxation. This is reported using a 100 mm visual analog scale from 0 - 100 where higher numbers indicate greater satisfaction.

Failure Rate of Endotracheal Intubation and Requirement for Alternative Airway Management Methods

时间窗: during rapid sequence intubation procedure, average time frame 30 minutes

Failure rate of endotracheal intubation and requirement for alternative airway management methods

次要结局

  • Incidence of Short-term Catheter Related Complications for Each Technique(during emergency department stay, average time frame 24 hours)

研究点 (2)

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