Intravenous Sodium Bicarbonate Verifies Intravenous Position of Catheters in Spontaneously Breathing Adult Volunteers
试验速览
- 阶段
- 2 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- transient increase in end tidal carbon dioxide
研究概览
简要总结
Vascular access in patients carries a significant risk of accidental extravasation of intravenous (IV) fluids and medications with the potential for tissue injury. This prospective controlled study assessed the diagnostic utility of using intravenous diluted sodium bicarbonate to confirm placement of IV catheters in volunteers . Diluted sodium bicarbonate or 0.9% normal saline, will be injected in a randomized order while end-tidal carbon dioxide in the exhaled air will be monitored. The investigators hypothesize that the injected bicarbonate will dissolve into carbon dioxide and water and cause a transient increase in the measured exhaled CO2.
The effect is unique to bicarbonate and will not appear once normal saline is injected. the safety of the administration of bicarbonate on the metabolic profile of the volunteers will be assessed by measurement of venous blood pH and electrolytes.
详细描述
Vascular access in patients carries a significant risk of accidental extravasation of intravenous (IV) fluids and medications with the potential for tissue injury. This prospective controlled study assessed the diagnostic utility of using intravenous diluted sodium bicarbonate to confirm placement of IV catheters in volunteers . Diluted sodium bicarbonate or 0.9% normal saline, will be injected in a randomized order while end-tidal carbon dioxide in the exhaled air will be monitored. The investigators hypothesize that the injected bicarbonate will dissolve into carbon dioxide and water and cause a transient increase in the measured exhaled CO2. Arbitrary increase of more than 10%in end-tidal carbon dioxide is considered as a positive response.
The effect is unique to bicarbonate and will not appear once normal saline is injected. the safety of the administration of bicarbonate on the metabolic profile of the volunteers will be assessed by measurement of venous blood pH and electrolytes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •no cardiovascular or respiratory disease
排除标准
- •ASA > II
- •Cardiovascular disease
- •Respiratory disease
- •renal failure
- •metabolic alkalosis
研究组 & 干预措施
sodium bicarbonate 4.2%
sodium bicarbonate 4.2% 50 m"l
干预措施: sodium bicarbonate 4.2% (Drug)
sodium bicarbonate 2.1%
sodium bicarbonate 2.1% 1 50 m"l
干预措施: diluted sodium bicarbonate 2.1% (Drug)
normal saline
50 m"l normal saline
干预措施: normal saline (Drug)
结局指标
主要结局
transient increase in end tidal carbon dioxide
时间窗: 4-12 seconds
Once sodium bicarbonate is injected the measured end-tidal carbon dioxide will transiently increase by at least 10% of baseline
次要结局
- Change in venous blood pH(10-20 minutes)
- Subjective adverse symptoms associated with injection of sodium bicarbonate(1 minute)
- change in venous blood sodium(10- 20 minutes)
- change in venous blood bicarbonate level(10-20 minutes)
- change in venous blood potasium level(10-20 minutes)
研究者
Dr. Ilan Keidan
Director, Pediatric Anesthesia, Sheba Medical center
Sheba Medical Center