Phase III Study to Assess the Utility of a New Innovative Technique Using Intravenous Bicarbonate to Verify the Correct Position of Patients Scheduled for Intravenous Bicarbonate
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- change in exhaled end tidal co2
研究概览
简要总结
The investigators use bicarbonate injected to an intravenous line and the changes in the exhaled end-tidal carbon dioxide to verify whether the IV line is in the vein or surrounding tissue
详细描述
The method was proved useful in previous phase I, II studies. Now the investigators move on to assess the method in a phase III study in oncological patients.
each patients which will be subjected to intravenous chemotherapy will be eligible ( see also inclusion/exclusion criteria).
Once consent obtained the patient will have an IV line placed. each line placed will be categorized by the clinical team into 3 categories:
- IV in place ready to use for chemotherapy ( good blood return)
- Doubtful position ( no blood return/ little blood return bu flushes well).
- IV not in place. Study design Category 1. IV bicarbonate 4.2% 20 cc and NS 20 cc in a randomized fashion Category 2. same as above Category 3. No injections
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-80 oncological disease requires intravenous chemotherapy
排除标准
- •refusal to participate
- •lung disease acute or chronic sPo2 < 92%, PaCO2 > 50
- •renal failure Creatinine > 2 mg%
- •metabolic alkalosis HCO3 > 30 meq/L
- •medication that affect bicarbonate levels: Bicarbonate, Diamox, Fusid
- •obesity BMI > 38
- •congestive heart failure EF < 40 % or clinical signs of congestive heart failure
研究组 & 干预措施
IV bicarbonate 4.2% 20 cc
injecting 20cc 4.2% to a newly administered IV line
干预措施: sodium bicarbonate 4.2% (Drug)
结局指标
主要结局
change in exhaled end tidal co2
时间窗: 1-3 minutes
the injection of bicarbonate in a vein cause a rapid and distinct change in exhaled end-tidal CO2
次要结局
未报告次要终点
研究者
Dr. Ilan Keidan
director pediatric anesthesia
Sheba Medical Center