Quantitative Ultrasound Assessment of Gastric Volume in Pregnant Women at Term
Solid food or fluid residue in the stomach is always a major concern when patients need medical procedures under sedation or general anesthesia, due to the high risk of pulmonary aspiration of the stomach contents. This is especially important in emergency procedures, when a fasting period is not observed. The aspiration of the stomach contents into one's lungs can lead to serious complications (such as severe respiratory failure). Information from a bedside ultrasound assessment of the stomach may be a very useful tool to decide whether or not it's safe to proceed, cancel or delay a surgical procedure.
The investigotrs hypothesize that a mathematical model can be constructed to predict clear fluid volume in the stomach of non-labouring pregnant patients, as it has been developed in healthy adult volunteers.
研究概览
详细说明
Food residue in the stomach of patients scheduled to have surgery is considered a major risk factor for pulmonary aspiration of gastric contents. The resulting respiratory compromise after aspiration is associated with significant morbidity and mortality. The risk of pulmonary aspiration is especially important in pregnant women, as they may often require surgery without having observed appropriate fasting. A bedside ultrasound assessment of the status of the gastric content would be of great value for the clinician. This technique has recently been shown very promising in non-pregnant patients and it is important to study its feasibility in the pregnant population.
In this study, patients fast overnight and are randomized to the following groups: empty, or various volumes of fluid (50, 100, 200, 300 or 400mL of apple juice before scanning). Their gastric contents are then assessed by an anesthesiologist, using ultrasound. The investigators aim to evaluate a standardized quantitative ultrasound assessment of gastric volume in non-labouring pregnant women.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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-
Ontario
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Toronto、Ontario、加拿大、M5G1X5
- Mount Sinai Hospital
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-
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:
- Volunteer non-labouring pregnant women at term (≥ 36 weeks)-
- 18 years or older
- ASA Physical Status I-III
- 50-120 kg of weight
- 150 cm of height or taller
- Ability to understand the rationale of the study assessments and to provide signed informed consent
- Written informed consent
Exclusion Criteria:
- Known pre-existing abnormal anatomy of the upper gastrointestinal tract
- History of upper GI tract surgical procedure
学习计划
研究是如何设计的？
设计细节
- 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 |
|---|---|
|
无干预：empty stomach
No fluid will be given to the patient prior to scanning.
|
|
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实验性的：50mL
50mL of water will be given to the patient prior to scanning
|
水
|
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实验性的：100mL
100mL of water will be given to the patient prior to scanning
|
水
|
|
实验性的：200mL
200mL of water will be given to the patient prior to scanning
|
水
|
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实验性的：300mL
300mL of water will be given to the patient prior to scanning
|
水
|
|
实验性的：400mL
400mL of water will be given to the patient prior to scanning
|
水
|
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 |
|---|---|---|
|
Correlation between ingested volume and CSA in antrum
大体时间：5-10 minutes
|
The patient will ingest 0, 50, 100, 200, 300 or 400mL of apple juice, and then the cross-sectional area (CSA) will be measured.
|
5-10 minutes
|
合作者和调查者
调查人员
- 首席研究员：Cristian Arzola, MD、Mount Sinai Hospital
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
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