Gastric Assessment of Pediatric Patients Undergoing Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Intra-rater reliability
研究概览
简要总结
The goal of this pilot prospective cohort study is to examine the reproducibility of gastric volume and emptying as measured by gastric ultrasound and its correlation to a gold-standard test for gastric emptying in the perioperative period in pediatric patients. The main questions it aims to answer are:
- What is the reliability (inter-rater variability between expert and novice assessors, and intra-rater variability) of a) the gastric antral cross-sectional area (CSA) and b) gastric volume using the Perlas US qualitative grading assessment, measured by using an ultrasound device in pediatric patients undergoing general anesthesia for elective surgery?
- What is the correlation between ultrasound assessment of gastric emptying by the antral-CSA and gastric emptying determined by the acetaminophen absorption test (AAT), the gold standard?
The study will include two cohorts. Cohort assignment will be based on age and anesthesia induction plan. Subjects >7yrs of age and expected to get an IV induction will be assigned to Cohort #1. Subjects <7yrs of age and not expected to get an IV induction will be assigned to Cohort #2.
- Cohort 1 will include abdominal ultrasound for gastric assessment AND the acetaminophen absorption test which includes administering enteral acetaminophen (tylenol) with 6 oz of water and drawing of blood samples through a peripheral intravenous line.
- Cohort 2 will include subjects for whom a peripheral intravenous line placement is not part of routine pre-operative care. Procedures for Cohort 2 will include abdominal ultrasound only in the pre-op area (no tylenol). This cohort is included to examine the reliability of measurements across age groups.
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
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Perioperative patients with ASA classification 1-2
- •Ages: 2 years- less than 18 years
- •Locations: Longwood and Waltham campuses of Boston Childrens Hospital
排除标准
- •History of gastrointestinal surgery
- •Gastrostomy
- •Known GI dysmotility (cohort 1 only)
- •Acetaminophen allergy (cohort 1 only)
- •Liver or renal dysfunction- pre-diagnosed or, if available, when serum biomarkers are 2 standard deviations above the highest value considered normal for age. (cohort 1 only)
- •Consumption of acetaminophen in the 4 hours prior (cohort 1 only)
结局指标
主要结局
Intra-rater reliability
时间窗: 1 year
Measured using the following quantitative and qualitative ultrasound assessments between a novice and an expert gastric ultrasound operator: * Qualitative using the previously published Perlas' US qualitative grading assessment * Grade 0- no contents visualized in supine and lateral position * Grade 1- contents visualized in the lateral decubitus position (RLD) only * Grade 2- contents visualized in the supine and RLD. * Quantitative assessment using the cross-sectional area as published by Spencer AO et al. * Measurement of the CSA: longitudinal diameter (D1), and the antero-posterior diameter (D2) in both supine and RLD. Then these will be used to calculate the cross-sectional area (CSA) = (π\*D1\*D2)/4.
Gastric Emptying
时间窗: 1 year
Outcome will be gastric emptying assessed by the change in antral CSA (measured in cm2) over time after acetaminophen administration, and this will be correlated to gastric emptying over the same period of time by the acetaminophen absorption test PK parameter, AUC60 mcg\*min/mL. As such, each patient will act as their own control. Correlation analysis will be applied to examine the performance of CSA measurements overtime using gastric ultrasound to determine gastric emptying compared to the acetaminophen absorption test as the gold standard.
Inter-rater reliability
时间窗: 1 year
Measured using the following quantitative and qualitative ultrasound assessments between a novice and an expert gastric ultrasound operator: * Qualitative using the previously published Perlas' US qualitative grading assessment * Grade 0- no contents visualized in supine and lateral position * Grade 1- contents visualized in the lateral decubitus position (RLD) only * Grade 2- contents visualized in the supine and RLD. * Quantitative assessment using the cross-sectional area as published by Spencer AO et al. * Measurement of the CSA: longitudinal diameter (D1), and the antero-posterior diameter (D2) in both supine and RLD. Then these will be used to calculate the cross-sectional area (CSA) = (π\*D1\*D2)/4. * Quantitative assessment using the cross-sectional area as published by Spencer AO et al. * Measurement of the CSA: longitudinal diameter (D1), and the antero-posterior diameter (D2) in both supine and RLD. Then these will be used to calculate the cross-sectional area (CSA)
次要结局
- Post-anesthetic outcomes(1 year)
研究者
Walid Alrayashi
Director, Regional Analgesia Program
Boston Children's Hospital