Gastric pH in Intubated Children - Part Two
Untersuchung Des Magen-pH in lntubationsanästhesie Bei Kindern - Teil Zwei
Fasting (according to ASA, ESA or institutional guidelines) is an important strategy to minimize the risk of regurgitation, vomiting and pulmonary aspiration during general anaesthesia; the effect of fasting time for clear fluid on gastric pH in children is goal of this study and can be investigated in children undergoing elective procedures in general anaesthesia and intubation without inconvenience or additional invasive procedure and hence without additional risk
Hypotheses: Gastric pH is higher in children that drink clear fluids until premedication before anaesthesia induction than in those that drink until 2 hours before anaesthesia induction
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Zurich、瑞士、8032
- University childrens Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
age > 1 / < 16 years ASA class l or ll elective surgery requiring general anaesthesia using tracheal intubation
Exclusion Criteria:
disease or dysfunction of gastrointestinal tract chronic diseases or conditions not compatible with ASA class l or ll
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：clear fluids until premedication
allowed to drink until premedication, aprox 30 minutes before anaesthesia induction.
Fasting for solids and non-clear fluids is six hours.
|
drinking of clear fluid in preoperative period
|
|
有源比较器：2 hours fluid fasting
allowed to drink until 2 hour before scheduled anaesthesia induction clear fluid Ingestion.
Fasting for solids and non-clear fluids is six hours.
|
drinking of clear fluid in preoperative period
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
胃酸碱度
大体时间：气管插管后10分钟内
|
在气管插管诱导麻醉后立即通过口胃管从注射器中取样的胃内容物测量胃 pH 值；插管后抽吸胃是我们机构中每个插管儿童的例行程序
|
气管插管后10分钟内
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
胃抽吸量
大体时间：气管插管后10分钟内
|
胃抽吸量是在气管插管诱导后麻醉期间立即通过口胃管在注射器中取样的胃内容物的量；插管后抽吸胃是我们机构中每个插管儿童的例行程序
|
气管插管后10分钟内
|
|
恢复单元中的术后恶心和呕吐 (PONV)
大体时间：恢复期，平均在麻醉结束后90分钟内
|
恢复期，平均在麻醉结束后90分钟内
|
|
|
subjective feeling of hunger/thirst
大体时间：baseline
|
subjective feeling of hunger/thirst given as "yes" or "no" answer
|
baseline
|
|
Behaviour during recovery period
大体时间：recovery period, on the average within 90 minutes after end of anaesthesia
|
Rating Scale1-5 by blinded nurse (5: severely agitated/emergence delir with subsequent drug therapy, 4: agitated/emergence delir; 3: slightly agitated; 2: complaining pain but cooperative; 1: cooperative)
|
recovery period, on the average within 90 minutes after end of anaesthesia
|
|
Behaviour during anaesthesia induction
大体时间：on the average within 20 minutes after arrival of patient in operating theatre
|
Rating scale1-5 by (blinded) anaesthetist: 1: cooperating - 2: anxious but cooperating - 3: hostile - 4: crying - 5: agitated/fighting
|
on the average within 20 minutes after arrival of patient in operating theatre
|
|
Nurse's Impression of patient's satisfactory
大体时间：baseline
|
subjective feeling of the Nurse regarding patient's satisfactory given as rating scale from 1 to 4
|
baseline
|
|
blood Ketone measurement
大体时间：intraoperative
|
measurement of blood Ketone with a portable poc Ketone measurement device
|
intraoperative
|
合作者和调查者
调查人员
- 首席研究员：Achim J Schmitz, MD、University Children's Hospital, Zurich
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- KEK-ZH Nr. 2011-0034 Amend3
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.