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临床试验/NCT01564030
NCT01564030已完成不适用

Qualitative Ultrasound Assessment of the Gastric Content of Pregnant Women at Term

Samuel Lunenfeld Research Institute, Mount Sinai Hospital2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2012年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
32
试验地点
2
主要终点
Reliability of the ultrasonographic diagnosis of the gastric status

研究概览

简要总结

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.

详细描述

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 fo 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, fluid (250 mL of apple juice before scanning) or solid (full breakfast). Their gastric contents are then assessed by 3 different anesthesiologists, using ultrasound. At the end of the scanning, the true stomach contents are revealed. The ability of the assessors to accurately predict stomach contents, as well as the inter-observer agreement, will be examined.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Investigator)

入排标准

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

入选标准

  • Volunteer non-laboring pregnant women >32 weeks gestation
  • 18 years or older
  • ASA status I-III
  • Weigh between 50 and 120kg
  • Height at least 150cm or taller
  • Written informed consent

排除标准

  • Known pre-existing abnormal anatomy of the upper GI tract
  • Protocol violation

结局指标

主要结局

Reliability of the ultrasonographic diagnosis of the gastric status

时间窗: 30 minutes

Three physicians trained in gastric ultrasound will be blinded to the treatment group the patient was in, perform an ultrasound, and try to guess whether the patient has an empty stomach, consumed fluids only, or consumed a full meal.

次要结局

  • Inter-observer agreement of gastric content diagnosis(30 minutes)

研究者

发起方
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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