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Completed

NCT Number: NCT05737641

Gastric Volume After Water or Jelly Ingestion

The aim of this study is to determine whether the fasting duration required for patients after consuming oral jelly is comparable to that after consuming water, prior to elective surgery.

International guidelines for perioperative fasting recommend abstaining from clear fluids for 2 hours to minimize the risk of regurgitation and aspiration pneumonia. However, there are no specific recommendations regarding the perioperative management of jelly consumption.

Current understanding emphasizes the benefits of minimizing preoperative fasting time, including preventing dehydration and metabolic complications like ketoacidosis, as well as potentially enhancing patient satisfaction.

Oral jelly consumption may offer advantages by improving preoperative hydration and providing some nutritional support prior to procedures.

This crossover study will involve 25 adult volunteers. In the first phase, participants will be randomly assigned to either oral intake of water or jelly, followed by the opposite intervention in the second phase. Gastric content and volume will be assessed using gastric ultrasound.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Hospitalar de Entre Douro e Vouga (CHEDV)

Santa Maria da Feira, Aveiro District, 4520-211, Portugal

About this study

Prolonged preoperative fasting is associated with unfavorable outcomes, inducing a catabolic state that may lead to metabolic disturbances such as ketoacidosis, insulin resistance, dehydration, and increased postoperative complications such as surgical site infection and delayed bowel function. To minimize fasting time, current guidelines from the American Society of Anesthesiology advise clear fluid intake (water, tea, coffee, pulp-free fruit juices, carbohydrate-rich beverages) up to 2 hours prior to elective procedures involving general anesthesia, regional anesthesia, or procedural sedation and analgesia. Solids fasting should extend to 6 to 8 hours, depending on the type of foods.

Jelly is a solid food, mostly composed of water. Among its other components, proteins, responsible for its solidification, and sugars stand out. Thus, it may be a form of oral hydration, associated with some nutritional value, but the appropriate preoperative fasting time is not explicitly stated in the guidelines.

An important cause of mortality and morbidity associated with tracheal intubation is the aspiration of gastric contents. It is important to ensure that restricting preoperative fasting time does not compromise patient safety, thereby increasing this risk. While carbohydrate-rich beverages are not associated with delays in gastric emptying, the same cannot be said for protein-containing liquids.

Gastric ultrasound is a non-invasive, bedside-available, and reliable method for quantitative and qualitative assessment of stomach contents. Although the minimum volume of gastric contents associated with increased risk of aspiration is not known, some studies demonstrate that volumes up to 1.5 mL/kg of clear fluids, in the absence of solid contents, are normal, commonly seen in fasting adults, and are not associated with an increased risk of pulmonary aspiration.

The aim of our study is to demonstrate that jelly ingestion, compared to water, is not associated with larger cross-sectional area of the gastric antrum, behaving similarly to clear fluids.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

water ingestion

Other

ingestion of water after an 8h-fasting period

jelly ingestion

Dietary Supplement

ingestion of jelly after an 8h-fasting period

Primary outcomes

  1. gastric antral cross-sectional area

    Time frame: 2 hours after intervention

    antral cross-sectional area measured by ultrasound in right lateral decubitus position (non-inferiority test)

Secondary outcomes

  1. gastric volume

    Time frame: 2 hours after intervention

    gastric volume calculated by the formula of Perlas et al

  2. gastric volume greater than 1.5 mL/Kg

    Time frame: 2 hours after intervention

    number of participants with gastric volume greater than 1.5 mL/kg

  3. Qualitative gastric evaluation

    Time frame: 2 hours after intervention

    Empty, fluid or solid

  4. hunger and thirst

    Time frame: 2 hours after intervention

    hunger and thirst on a visual analogue scale from 0 to 10

Sponsors and collaborators

Lead sponsor

Centro Hospitalar de Entre o Douro e Vouga

Other

Registry information

Official study title

Ultrasonographic Evaluation of Gastric Content and Volume After Oral Ingestion of Water or Jelly in Volunteers - A Randomised Controlled Non-inferiority Clinical Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Feb 21, 2023
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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