Clinical Trial Radar

This study, titled the "Gastric Ultrasound for Estimation of the Aspiration Risk Study," investigates a safer approach to anesthesia for certain patients. Let's break down what that means.

📋 Trial Overview & Purpose

The main goal of this research is to see if a simple ultrasound of the stomach can accurately predict the risk of a serious complication called pulmonary aspiration. This happens when stomach contents enter the lungs during anesthesia, which can lead to pneumonia and other lung injuries.

Currently, doctors rely on standard fasting guidelines (e.g., "no food or drink after midnight") to ensure a patient's stomach is empty before a procedure. However, these rules may not be effective for everyone, especially patients with certain medical conditions or those undergoing emergency trauma surgery. This study aims to determine if ultrasound is a better tool than fasting guidelines alone for assessing this risk.

🔬 Key Medical Terms

• Respiratory Aspiration of Gastric Contents: This is the medical term for food, liquid, or stomach acid accidentally entering the airway and lungs. It's a significant risk during anesthesia because the body's natural reflexes that prevent this are temporarily disabled.
• Gastric Ultrasound: A non-invasive imaging test that uses sound waves to create a picture of the stomach. It can help doctors see if the stomach contains solid food, liquids, or is empty.

🧪 Study Design

This is an observational study, meaning researchers are observing and collecting data without introducing a new treatment.

• Study Type: Case-Control. Researchers will compare different groups of patients.
• Interventions:
  1. Questionnaire: Patients will be asked about their last meal.
  2. Gastric Ultrasound: A non-invasive ultrasound of the stomach will be performed before their scheduled procedure.
• Groups (Arms): The study will enroll 200 participants and compare four groups:
  • Patients who followed fasting guidelines.
  • Patients who did not follow fasting guidelines.
  • Trauma patients who followed fasting guidelines.
  • Trauma patients who did not follow fasting guidelines.

📢 For more details on the study groups, please refer to the 'Study Plan' tab in the Trial Radar Card View.

✅ Participation & Eligibility

The study is actively recruiting adults who are scheduled for specific procedures.

• Inclusion Criteria: Participants must be 18 years or older, scheduled for an upper GI endoscopy or trauma surgery, and expected to have an oral-gastric tube placed as part of their care.
• Exclusion Criteria: Individuals who are pregnant, have a history of gastric bypass surgery, or are unwilling to undergo the ultrasound are not eligible.

📢 For a complete list of eligibility rules, please check the 'Participation' tab in the Trial Radar Card View.

📊 Outcomes Measured

The primary goal is to measure and compare the amount of leftover contents in the stomach across the different patient groups.

• Primary Outcome: Researchers will use the ultrasound to measure the volume of gastric contents. They want to see if this volume is within the range considered safe for anesthesia. This measurement will be taken just once, prior to the procedure.

📈 Why This Research is Important

If gastric ultrasound proves to be a reliable way to assess aspiration risk, it could lead to significant changes in pre-operative care. It might allow for more personalized fasting instructions, potentially reducing surgery cancellations and, most importantly, preventing a dangerous complication. This could make surgery safer for everyone, especially for high-risk and emergency patients.

This information is for educational purposes. Always consult with a qualified healthcare provider for medical advice and to discuss whether participating in a clinical trial is right for you.

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