Ultrasound Evaluation of Gastric Content in Diabetic and Non-Diabetic Term Pregnant Women: An Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Roukhomovsky equation for gastric volume (mL)
研究概览
简要总结
Perioperative aspiration is particularly concerning in pregnant women due to anatomical changes. To mitigate this risk, pre-anesthetic fasting is recommended, with varying guidelines. Gastric ultrasound can non-invasively assess stomach contents, and mathematical models help estimate stomach volumes using the gastric antral cross-sectional area (CSA).
This study aims to compare CSA and estimated gastric volumes through ultrasound in fasting diabetic and non-diabetic pregnant women scheduled for cesarean section, as diabetes may affect stomach fullness. Additionally, it will investigate the relation between demographic and clinical variables and CSA values.
This research can shed light on diabetes' influence on aspiration risk in pregnancy and evaluate fasting guidelines, underscoring the significance of gastric ultrasound.
详细描述
Perioperative aspiration of stomach contents is rare but is a serious complication of anesthesia and is associated with high morbidity and mortality. In pregnant women, it is known that the risk of aspiration is high even after standard preoperative fasting, due to anatomical changes such as the displacement of the stomach by pressure from the uterus, the sliding of the lower segment of the esophagus into the thorax, the relaxation of the lower esophageal sphincter, and the smooth muscle relaxation induced by progesterone.
In cases where regional anesthesia is contraindicated, various measures, including prokinetic and antacid medications, rapid-sequence anesthetic induction, and tracheal intubation, are used to reduce the risk and severity of pulmonary aspiration. However, the most commonly used measure is pre-anesthetic fasting in the patient. The European Society of Anaesthesiology (ESA) recommends fasting for ≥2 hours after clear liquids and 6 hours after light meals before elective surgery, including in pregnant patients.
The American Society of Anesthesiologists (ASA), on the other hand, recommends longer fasting times in pregnant patients without specifying the duration.
Aspiration risk in pregnant women is multifactorial. The type and volume of stomach contents, which are the main risk factors for aspiration, can be easily evaluated preoperatively with gastric ultrasonography. The presence of solids or thick liquids indicates a high risk of aspiration, independent of stomach volume.
However, in the presence of clear liquid, the risk of aspiration is generally linked to the volume of liquid in the stomach. The clear stomach volume limits that increase the risk of aspiration are controversial.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients belonging to American Society of Anesthesiology (ASA) physical status class II-III.
- •Aged between 18 and 40 years.
- •Gestational age greater than 37 weeks.
- •BMI< 35 kg/m2
排除标准
- •Patients belonging to American Society of Anesthesiology (ASA) physical status class III-IV.
- •Patients under the age of
- •Patients taken to surgery on an emergency basis.
- •Relatives of patients who do not provide consent.
- •Pregnant patients with upper gastrointestinal (GI) diseases and pathologies.
- •Body Mass Index (BMI) greater than 35 kg/m
- •Patients with a history of using medications that affect gastrointestinal motility (e.g., opioids).
- •Severe organ dysfunction.
- •Pre-existing neurological deficits.
- •Intellectual disabilities.
- •Anatomical deformities.
结局指标
主要结局
Roukhomovsky equation for gastric volume (mL)
时间窗: 2 month
Roukhomovsky Gastric residual volume (mL) = 0.18 x right lateral CSA (mm2) + 0.11 x semi-recumbent CSA (mm2) - 62.4
Antral cross-sectional area (in square centimeters)
时间窗: 2 months
Ultrasonographic gastric antral cross-sectional area in square centimeters=(D1 × D2 × π)/4. Anteroposterior diameter of the antrum from serosa to serosa: D1 (centimeters), craniocaudal diameter: D2 (centimeters)
Perlas equation for gastric volume (mL)
时间窗: 2 months
Perlas Gastric residual volume (mL) = 27.0 + 14.6 x right lateral CSA (cm2) - 1.28 x age (years).
次要结局
- Relationship between demographic/clinical features and CSA (cm2) / Perlas GV (mL/kg) / Roukhomovsky GV (mL/kg) values.(2 months)
研究者
KAIRATBEK MIIZAMOV
Principal Investigator
Sisli Hamidiye Etfal Training and Research Hospital