Does Pre-operative Gastric Ultrasound Influence Anaesthetic Decision-Making in Chronic Pain Patients? A Prospective Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- The proportion of patients in whom pre-procedural gastric ultrasound resulted in a change to the pre-defined anesthetic management plan.
研究概览
简要总结
Gastric POCUS has been validated and shown to be an accurate diagnostic tool in both healthy individuals and medically complex patient populations. Regional anaesthesiologists and pain management physicians frequently provide sedation or anaesthetic care for medically complex patients who fall outside the limited applicability of existing fasting guidelines, including patients with chronic pain, poor acute-on-chronic pain control, and those receiving acute or chronic opioid therapy. These patients are at risk of delayed gastric emptying and may therefore benefit from additional pre-procedural assessment using gastric ultrasound prior to elective interventions
详细描述
This study is the first prospective evaluation of gastric ultrasound in this high-risk, understudied population, incorporating quantitative opioid exposure and focusing on its impact on real-time anaesthetic decision-making. By linking gastric ultrasound findings to changes in peri-procedural management, this work extends gastric POCUS from a diagnostic tool to a clinically actionable risk-stratification strategy.
The aim of this study is to determine whether pre-operative gastric POCUS provides decision-relevant information that influences peri-operative aspiration risk assessment and leads to modification of pre-defined anaesthetic management plans in chronic pain patients undergoing elective interventional procedures under sedation.
Pre-procedural gastric ultrasound will be performed immediately before initiation of sedation by the investigators experienced in gastric point-of-care ultrasound, each having completed at least 30 supervised examinations. A standardised scanning protocol was used. Qualitative assessment of gastric contents was performed in the supine position and in the right lateral decubitus position. When patient-related factors precluded these positions, scanning was performed in a semi-recumbent position at approximately 45°.
Gastric contents will be classified qualitatively as:
- Empty
- Fluid (homogeneous hypoechoic contents)
- Solid or mixed (heterogeneous contents with echogenic material) When fluid content was identified, the gastric antral cross-sectional area (CSA) was measured at rest in a parasagittal plane at the level of the abdominal aorta using the serosal tracing method, as previously described. Gastric fluid volume was estimated using the validated Perlas mathematical model.
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
- •Patients were eligible for inclusion if they met all of the following criteria:
- •Age ≥18 years
- •Scheduled for elective chronic pain interventional procedures under procedural sedation
- •Adherence to standard preoperative fasting guidelines (≥6 hours for clear fluids and ≥8 hours for solids)
- •Presence of at least one clinical factor associated with delayed gastric emptying or increased risk of pulmonary aspiration, including:
- •Chronic opioid use (≥2 weeks)
- •Acute opioid administration within 24 hours prior to the procedure
- •Poorly controlled acute-on-chronic pain
- •Diabetes mellitus without established autonomic neuropathy
- •Symptoms of gastroesophageal reflux
- •Reduced functional mobility
- •ASA physical status II-III
排除标准
- •Patients will be excluded if any of the following present:
- •Age <18 years
- •Previous gastric or esophageal surgery
- •Known pregnancy
- •Known hiatal hernia
- •Severe neurological disorders affecting swallowing or gastric motility
- •Established autonomic neuropathy affecting gastric emptying (e.g. advanced diabetic gastroparesis)
- •Morbid obesity (body mass index ≥35 kg·m-²), due to known limitations in gastric ultrasound image acquisition and reduced validity of volume estimation models
- •Inability to provide informed consent
结局指标
主要结局
The proportion of patients in whom pre-procedural gastric ultrasound resulted in a change to the pre-defined anesthetic management plan.
时间窗: 1- 2 hours
The Percentage of patients from the total number of patients involved in the study, in whom pre-procedural gastric ultrasound reveals signs of high aspiration risk which needed a change to the pre-defined anesthetic management plan, A management change was defined as any deviation from the originally documented sedation or airway strategy following review of ultrasound findings. (Patients with solid or mixed gastric contents, or fluid contents with a gastric volume of \>1.5 ml·kg-¹ body weight are classified as having a high aspiration risk).
次要结局
- Prevalence of high-risk gastric contents despite adherence to fasting guidelines(1- 2 hours)
- Associations between gastric ultrasound findings and patient-related factors, including opioid use and comorbidities(1-2 hours)
- Qualitative and quantitative gastric ultrasound findings(1-2 hours)
研究者
JINAN AHMED JAMEEL AL ALOOSI
Consultant Anesthesiologist
Danat Al Emarat Hospital