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临床试验/NCT01219322
NCT01219322Unknown1 期

Intravenous Bicarbonate Identifies the Correct Position of Intravenous Catheter

Sheba Medical Center1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2010年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
入组人数
30
试验地点
1
主要终点
change in end-tidal carbon dioxide

研究概览

简要总结

Extravasation is an unintentional injection or leakage of fluids in the perivascular or subcutaneous space. Extravasation can be associated with tissue injury with various level of severity and long term consequences. Currently the confirmation of intravenous location of the Intravenous (IV) catheter requires close observation of the insertion site with sufficient infiltration in the perivascular area to allow detection of swelling, discoloration and discomfort. Under Anesthesia direct observation is frequently prohibited. IV sodium bicarbonate (SB) is used frequently to treat different metabolic conditions and is known to cause a temporary elevation of exhaled carbon dioxide. This study aim is to evaluate the safety and efficacy of intravenous SB as a detector of intravenous placement of an IV line in anesthetized patients.

Patients and Methods: The study has three parts, in part 1, the safety of subcutaneous injection of sodium bicarbonate was evaluated in 6 rats. In each animal the macroscopic and microscopic effects were evaluated and a safe dilution was determined. In the second part of the study the investigators will evaluated the efficacy of IV diluted SB to detect the proper location of IV catheters. 20 adult patients age 20 to 50 years will be enrolled. Patients all under general anesthesia with standard controlled ventilation via endotracheal tube. The correct placement of IV catheter will be confirmed by easy aspiration of blood from newly placed IV catheter. In each patient a bolus of 50 cc of 0.5 meq/cc SB or volume equivalent of normal saline will be injected in random order. The data collection will include patient's demographics, the presence or absence of an increase in the expired end-tidal carbon dioxide, onset and peak changes of end-tidal carbon dioxide as well as the hemodynamic changes after each injection.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy (American Society of Anesthesiologists [ASA] I or II) volunteers

排除标准

  • respiratory disease
  • active smoking
  • cardiovascular disease
  • renal disease

研究组 & 干预措施

intravenous bicarbonate

Experimental

Intravenous bicarbonate(05meq/cc ) 50 cc will be injected.

干预措施: Sodium bicarbonate (Drug)

Intravenous injection of 50 cc normal saline

Placebo Comparator

Injection of volume equivalent of normal saline to compare the establish the effect of same volume as the experimental drug

干预措施: normal saline (Drug)

结局指标

主要结局

change in end-tidal carbon dioxide

时间窗: 0.5-2 minutes

intravenous bicarbonate injected intravenously will cause an increase in end-tidal carbon dioxide within minutes

次要结局

未报告次要终点

研究者

申办方类型
Other Gov

研究点 (1)

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