Gastric Volume After Oral Ingestion of Water or Jelly in Volunteers

Study Overview
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Brief Summary
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The aim of the study is to understand whether the time that patients should fast after oral ingestion of jelly is similar to that of water, before elective surgery. International guidelines on perioperative fasting recommend 2 hours with no clear fluids ingestion to reduce the likelihood of regurgitation and aspiration pneumonia. But nothing is recommended about the perioperative management of jelly ingestion. 25 adult volunteers will be included on a crossover study. The first intervention will be randomized (oral intake of water or jelly) and in a second moment all participants will be submitted to the opposite intervention. Gastric content and volume will be evaluated through ultrasound. Exclusion criteria include morbid obesity, pregnancy, alcohol abuse and diseases or drugs that can prolong or accelerate gastric emptying such as gastric or esophageal surgery, diabetes mellitus, prokinetic or opioid use. Nowadays, the benefits of reducing preoperative fasting time are well known, such as avoiding dehydration and metabolic complications like ketoacidosis. It can also improve patient satisfaction. Oral jelly may improve preoperative hydration while also providing some nutritional support prior to procedures.

Official Title
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Ultrasonographic Evaluation of Gastric Content and Volume After Oral Ingestion of Water or Jelly in Volunteers - A Crossover Study

Conditions
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Fasting, Surgery, Ultrasound Therapy; Complications, Aspiration Pneumonia Due to Regurgitated Food

Intervention / Treatment
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* Other: water ingestion
* Dietary Supplement: jelly ingestion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult volunteers working in the hospital Centro Hospitalar de Entre o Douro e Vouga (CHEDV) Exclusion Criteria: morbid obesity pregnancy alcohol abuse diseases or drugs that can prolong or accelerate gastric emptying such as gastric or esophageal surgery, diabetes mellitus, prokinetic or opioid use, hypothyroidism intolerance to any of the components of jelly

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The first intervention will be randomized (oral intake of water or jelly) and in a second moment all participants will be submitted to the opposite intervention.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: water ingestion<br>Ingestion of 102 mL of fresh water | Other: water ingestion<br>* ingestion of water after an 8h-fasting period<br>|
| Active Comparator: jelly ingestion<br>ingestion of 100 gr strawberry jelly | Dietary Supplement: jelly ingestion<br>* ingestion of jelly after an 8h-fasting period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gastric antral cross-sectional area | antral cross-sectional area measured by ultrasound in lateral decubitus | 2 hours after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gastric volume | gastric volume calculated by the formula of Perlas et al | 2 hours after intervention | 
| gastric volume greater than 1.5 mL/Kg | number of participants with gastric volume greater than 1.5 mL/kg | 2 hours after intervention | 
| Qualitative gastric evaluation | Empty, clear fluid or solid | 2 hours after intervention | 
| hunger and thirst | hunger and thirst on a visual analogue scale from 0 to 10 | 2 hours after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preoperative Fasting, Elective Surgery, Ultrasound, Gastric Volume, Jelly, regurgitation, Aspiration pneumonia