Evaluation of Incidence of Stomach Fullness in Elective Surgical Patients and Investigation of Associated Factors: Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 404
- 试验地点
- 1
- 主要终点
- Incidence of Full Stomach in Elective Surgical Patients as Assessed by Ultrasound
研究概览
简要总结
The aim of this prospective, observational study is to evaluate the incidence of residual gastric content in elective surgical patients who adhered to preoperative fasting guidelines and to investigate associated patient-related factors. Ultrasound (USG) has been identified as a valuable tool for assessing residual gastric content, and this study compares its efficacy against traditional questionnaire-based predictions. The study also examines the practicality and accuracy of different gastric volume estimation formulas and evaluates their correlation with aspiration risk.
A total of 475 patients were enrolled in the study, of whom 404 completed both the questionnaire and USG examination. All participants were adult patients scheduled for elective surgery, following standard fasting protocols. The ultrasound examination assessed the presence of solid or fluid content in the stomach, and patients were classified according to qualitative Perlas risk scores (Grade 0: Low, Grade 1: Moderate, Grade 2: High risk of aspiration). The questionnaire collected patient-reported factors, such as symptoms of early satiety, history of cholelithiasis, and comorbidities like diabetes or chronic obstructive pulmonary disease (COPD).
The primary objective of this study was to evaluate the efficacy of USG in detecting residual gastric content and compare it with questionnaire-based risk predictions. Logistic regression analysis identified early satiety and cholelithiasis as significant predictors of a full stomach and higher aspiration risk. Fasting duration was found to have a protective effect, reducing the likelihood of a full stomach. While many patient characteristics traditionally associated with delayed gastric emptying, such as age and diabetes, did not significantly correlate with the outcomes, early satiety and cholelithiasis proved to be key factors influencing gastric content.
In addition, this study explored the performance of several gastric volume estimation formulas, including the Michiko, Bouvet, and Perlas 2019/2020 formulas. The findings indicated significant limitations in these formulas, with many patients being estimated to have negative gastric volumes, particularly by the Michiko and two of Perlas' formulas. This highlights the inadequacies of current formulas in accurately predicting gastric volume, necessitating further refinement and development of new models that better account for physiological variability.
Furthermore, the agreement between questionnaire-based predictions and USG findings was assessed using Cohen's Kappa, which indicated fair agreement (Kappa value = 0.282). This suggests that while the questionnaire can serve as a screening tool to identify patients at risk of aspiration, it cannot replace the accuracy and reliability of USG in clinical practice.
Secondary objectives of the study included comparing the time-efficiency and ease of implementation between USG and the questionnaire-based assessments. USG proved to be more time-efficient, taking an average of 2.5 minutes per examination, compared to 3-5 minutes for completing the questionnaire. This speed, combined with its objective nature, underscores USG's value as a practical tool in the preoperative setting.
In conclusion, USG was found to be an effective and efficient tool for assessing residual gastric content and predicting aspiration risk, outperforming traditional questionnaire-based assessments. The inadequacy of current gastric volume estimation formulas points to the need for further research to develop more accurate and context-specific assessment tools. Comprehensive preoperative evaluation incorporating USG and patient-reported symptoms may improve patient safety by reducing the risk of aspiration during elective surgery.
详细描述
This study is a prospective observational research project designed to evaluate the incidence of residual gastric content in patients scheduled for elective surgery and to investigate patient-related factors that influence gastric emptying. The study primarily employs ultrasonography (USG) as a tool for assessing the presence of residual gastric content and compares its efficacy with traditional questionnaire-based assessments. Additionally, the study examines the utility and accuracy of various gastric volume estimation formulas, assessing their correlation with observed gastric content and aspiration risk.
Study Design:
Participants were enrolled based on pre-defined inclusion and exclusion criteria, including adult patients scheduled for elective surgery who adhered to standard preoperative fasting guidelines. Following a detailed informed consent process, patients were asked to complete a preoperative questionnaire, which gathered data on demographic characteristics, medical history, and patient-reported symptoms, such as early satiety, history of cholelithiasis, and other relevant comorbidities. Ultrasound examinations were performed by a single trained investigator to ensure consistency in imaging and interpretation.
USG was utilized to assess residual gastric content, including both solid and fluid content. The antrum cross-sectional area was measured in the supine and right lateral decubitus positions, and gastric volume was estimated using four different formulas: Michiko, Bouvet, two fo Perlas' formulas developed in differnet investigations. Patients were classified into three groups according to the Perlas risk score, which is based on ultrasound findings of gastric content (Grade 0 = low risk, Grade 1 = moderate risk, Grade 2 = high risk of aspiration). The primary outcome was the identification of a full stomach, defined as the presence of solid content or fluid contentbased on ultrasound findings.
Registry Procedures and Quality Control:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •scheduled for elective surgery
- •adhered to preoperative fasting guidelines
- •provided written informed consent
排除标准
- •children under 18 years of age
- •pregnant women
- •patients requiring emergency surgery
- •patients with a history of previous stomach surgery
- •patients who did not complete the sufficient fasting period (less than 8 hours)
- •patients with whom reliable cooperation for questionnaire completion could not be established (e.g., inability to provide reliable answers)
- •patients who could not be positioned on their right side due to clinical conditions
- •patients in whom sufficient quality imaging of the gastric antrum could not be obtained
结局指标
主要结局
Incidence of Full Stomach in Elective Surgical Patients as Assessed by Ultrasound
时间窗: At the time of preoperative assessment, within 2 hours prior to surgery.
The number of participants with full stomachs, as determined by the presence of solid content or fluid content using preoperative gastric ultrasound. Full stomach is defined as either solid content or clear fluid in the supine or right lateral decubitus positions.
次要结局
- Correlation Between Preoperative Fasting Duration and Incidence of Full Stomach as Assessed by Ultrasound(At the time of preoperative assessment, within 2 hours prior to surgery.)
- Perlas Risk Score for Aspiration Risk as Assessed by Ultrasound(At the time of preoperative assessment, within 2 hours prior to surgery.)
- Agreement Between Questionnaire-Based Risk Prediction and Ultrasound Findings for Aspiration Risk(At the time of preoperative assessment, within 2 hours prior to surgery.)
- Time Efficiency of Ultrasound vs. Questionnaire-Based Gastric Content Assessment(At the time of preoperative assessment, within 2 hours prior to surgery.)
- Gastric Volume Estimation Using Multiple Formulae and Correlation with Aspiration Risk(At the time of preoperative assessment, within 2 hours prior to surgery.)
研究者
Başar Erdivanlı
Assoc. Prof.
Recep Tayyip Erdogan University