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临床试验/NCT05946447
NCT05946447已完成不适用

Intra- and Interrater Reliability of Quantitative Ultrasound Assessment of Gastric Content in Term Parturients Before Elective Caesarean Delivery

Samuel Lunenfeld Research Institute, Mount Sinai Hospital2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年7月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Antral cross-sectional area (right lateral decubitus)

研究概览

简要总结

The presence of solid food or fluid residue in the stomach is always a major concern when patients require 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 could not be observed. Pulmonary aspiration of gastric content is a serious perioperative complication of obstetric anesthesia, and it is associated with morbidity and mortality. Information from a bedside ultrasound assessment of the stomach may be a very useful resource to decide whether it's safe to proceed, cancel or delay a surgical procedure. The ultrasound assessment of the stomach content has shown to be very feasible and practical in non-pregnant patients. However, it has not been determined whether the competence reached by anesthesiologists in non-pregnant subjects can be transferred to the obstetric population, especially in term pregnant patients where it could be difficult to identify the stomach because of the presence of the gravid uterus. Although quantitative assessment of the gastric antrum cross-sectional area in terms of intra- and interrater reliability has been evaluated in non-pregnant adults, it remains to be evaluated in pregnant patients. Furthermore, it has not been determined whether the performance of novice operators is comparable to expert operators in the gastric quantitative assessment. This study aims to determine whether trained anesthesiologists can reliably assess the stomach content of pregnant patients by ultrasound, evaluating the inter- and intra-rater reliability of quantitative gastric ultrasound in term pregnant patients comparing anesthesiologists of different level of expertise. The investigators hypothesize a substantial to almost perfect agreement in the intra- and interrater reliability of the antral cross-sectional area among raters in term pregnant patients scheduled for elective cesarean delivery.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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

  • non-laboring term pregnant women scheduled for cesarean delivery under neuraxial anesthesia
  • ≥37 weeks gestational age
  • ≥18 years of age
  • ASA physical status II-III
  • weight 50 to 120 kg
  • height ≥150 cm
  • ability to understand the rationale of the study evaluations.

排除标准

  • multiple pregnancy
  • known (reported by the study subject) anomalous anatomy of the upper gastrointestinal tract
  • previous surgical procedures on the esophagus, stomach or upper abdomen
  • patients not following our institutional fasting instructions (8 hours after a meal and 2 hours for clear liquids)

研究组 & 干预措施

Gastric Ultrasound

Experimental

Ultrasound measurements of the antrum will be recorded.

干预措施: Ultrasound (Device)

结局指标

主要结局

Antral cross-sectional area (right lateral decubitus)

时间窗: 5 minutes

The cross-sectional area (in centimeters squared) of the antrum will be measured with the patient in right lateral decubitus position, using the ultrasound machine. Measurements will be done 3 times, by 2 investigators.

Antral cross-sectional area (supine position)

时间窗: 5 minutes

The cross-sectional area (in centimeters squared) of the antrum will be measured with the patient in supine position, using the ultrasound machine. Measurements will be done 3 times, by 2 investigators.

次要结局

  • Inter-rater reliability calculation(5 minutes)
  • Grading of stomach contents(5 minutes)
  • Gastric volume (supine position)(5 minutes)
  • Intra-rater reliability calculation(5 minutes)
  • Gastric volume (right lateral decubitus)(5 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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