Gastric Emptying
Conditions
Keywords
Preoperative fasting, Liquid meal, Gastric ultrasound
Brief summary
Perioperative fasting is an essential patient safety measure to reduce the risk of pulmonary aspiration of gastric contents, a rare but potentially catastrophic complication of anesthetic and airway management. Anesthesiologists' concern about aspiration and the increasing awareness towards the negative impact of prolonged restriction of oral intake have shaped the current fasting guidelines. However, due to the perceived safety of prolonged fasting and practical considerations, adoption of the fasting guidelines is suboptimal. Gastric ultrasound is a quick, non-invasive method to evaluate gastric contents and aspiration risk. Gastric ultrasound can accurately discriminate between solid particles and fluid content, and mathematical models can reliably predict the volume of the gastric contents from the gastric antral area (GAA). This project aims to use gastric ultrasound to provide new data that can support management strategies in perioperative patients, that ensure both a low aspiration risk and an adequate nutritional support. The investigators will test the hypothesis that commercially available liquid meals can be safely used preoperatively. A pilot crossover, study on healthy volunteers will be conducted to determine the gastric emptying time of high-calorie drinks, as compared to clear fluid.
Interventions
DIETARY_SUPPLEMENTIntervention #1: ProvideXtra Drink
Fasted subjects will be offered 200 ml of ProvideXtra and will be asked to ingest it at a comfortable rate. Subsequent gastric ultrasound examinations will be performed half-hourly (up to 6 hours) to determine the volume of the gastric contents. The intervention ends when the stomach appears to be empty again on ultrasound.
DIETARY_SUPPLEMENTIntervention #2: Fresubin Energy Drink
Fasted subjects will be offered 200 ml of Fresubin Energy Drink and will be asked to ingest it at a comfortable rate. Subsequent gastric ultrasound examinations will be performed half-hourly to determine the volume of the gastric contents. The intervention ends when the stomach appears to be empty again on ultrasound.
DIETARY_SUPPLEMENTIntervention #3: Generic Glucose Solution
Fasted subjects will be offered the glucose solution and will be asked to ingest it at a comfortable rate. Subsequent gastric ultrasound examinations will be performed half-hourly (up to 6 hours) to determine the volume of the gastric contents. The intervention ends when the stomach appears to be empty again on ultrasound.
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
3 interventions will be administered in fasted healthy volunteers in a random sequence on 3 different days.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* ASA 1 and 2
Exclusion criteria
* Allergy or intolerance to any of the study products or the ingredients * Previous esophageal, gastric, or duodeno-pancreatic surgery * Gastric banding or large hiatal hernia * mmobility * Contraindication to right lateral positioning * Gastrointestinal diseases and disturbances * Participation in another, possibly interfering study * Diabetes mellitus * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastric emptying time | Repeated ultrasound examinations will be performed every 30 minutes after the ingestion of the study product up to 6 hours after ingestion to determine whether the stomach has completely emptied. | Time since ingestion of any of the study products until an empty stomach can be determined on ultrasound |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gastric volume at prespecified intervals after ingestions | Ultrasound examinations will be repeated every 30 minutes after the ingestion of the study product up to 6 hours and the gastric antrum area and the gastric antrum cross-sectional area will be measured to estimate the volume of the gastric content. | The volume of the gastric content determined using ultrasound |
Countries
Austria
Outcome results
None listed