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临床试验/NCT03555604
NCT03555604已完成不适用

Evaluation of the Effect of Body Mass Index on Gastric Volume With Ultrasound in Term Pregnant Women

Augusta University1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2018年5月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
1
主要终点
Cross sectional area of gastric antrum

研究概览

简要总结

This study seeks to determine if a relationship exists between gastric antrum cross-sectional area measured using ultrasound and BMI in term pregnant women (>37 weeks gestation).

详细描述

After approval by the Institutional Review Board, the investigators will obtain consent from patients. The consent will be obtained by the authorized personnel as per protocol, in which the investigators will explain to the patient the procedure, benefit, risk, cost and, confidentiality. The investigators plan to get the consent immediately after the patient arrived at the unit to avoid any interference with the delivery process. If the patient needs to go to an emergency cesarean section. This patient is not going to be included in the study. A gastric ultrasound with a low frequency (1-5 Hz) curvilinear array transducer using a Philips (CX-50) (Bothell, WA. USA) with image compounding technology, will be performed in each patient. The ultrasound procedure will be performed in the supine position and in a semi-recumbent right lateral position. The antrum will be identified in the sagittal plane between the liver, pancreas and aorta between peristaltic contractions. The ultrasound will be performed in each patient, in each position by three operators: two staff anesthesiologists and an anesthesia resident in presence of a medical student who will make sure that the standards for the procedure are uniform between operators (three images will be recorded by each operator per position in each patient). A qualitative assessment will be initially made, consisting of three grades: Grade 0, no fluid evidenced; Grade 2, clear fluid is evidenced only in right lateral decubitus position, and Grade 3, fluid is evidenced in both positions. Quantitative measurement of the cross-sectional area of the antrum (CSA) will be done by means of free tracing calipers. The full-thickness of the gastric wall will be included in the measurement and the average from the three images of each operator will be recorded. CSA will be calculated using the following formula:

CSA =(π x mean anteroposterior diameter x mean longitudinal diameter)/4

In addition to qualitative and quantitative ultrasound measures, the investigators will record demographic variables including age, BMI, weeks of gestation, gravity and parity.

The investigators plan to evaluate the existence of a relationship between cross-sectional area of the antrum (CSA) and BMI in term pregnant women using measurements of the CSA taken with free tracing calipers in ultrasound

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

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

入选标准

  • Pregnant patients >37 weeks of gestation
  • Age older than 18 years
  • NPO status >6 hours

排除标准

  • Unwillingness to participate in the study
  • Diagnosis of upper gastrointestinal disease
  • Episode of vomiting within the last 6 hours
  • Patients taking gastric pro-kinetic medications
  • Diabetes mellitus
  • Prior gastric, esophageal or upper abdominal surgery
  • Allergy to US gel

结局指标

主要结局

Cross sectional area of gastric antrum

时间窗: 10 minutes

Cross sectional area of gastric antrum

次要结局

  • Fasting time(8 hours)
  • BMI(10 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Efrain Riveros Perez, MD

Assistant Professor Department of Anesthesiology and Perioperative Medicine

Augusta University

研究点 (1)

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