Skip to content

Gastric Volume After Water or Jelly Ingestion

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05737641
Enrollment
25
Registered
2023-02-21
Start date
2022-12-01
Completion date
2024-08-25
Last updated
2024-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Preoperative Fasting, Elective Surgery, Ultrasound, Gastric Volume, Jelly, Regurgitation, Aspiration pneumonia

Brief summary

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.

Detailed description

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.

Interventions

ingestion of water after an 8h-fasting period

DIETARY_SUPPLEMENTjelly ingestion

ingestion of jelly after an 8h-fasting period

Sponsors

Centro Hospitalar de Entre o Douro e Vouga
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Intervention model description

RCT crossover study

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
gastric antral cross-sectional area2 hours after interventionantral cross-sectional area measured by ultrasound in right lateral decubitus position (non-inferiority test)

Secondary

MeasureTime frameDescription
gastric volume2 hours after interventiongastric volume calculated by the formula of Perlas et al
gastric volume greater than 1.5 mL/Kg2 hours after interventionnumber of participants with gastric volume greater than 1.5 mL/kg
Qualitative gastric evaluation2 hours after interventionEmpty, fluid or solid
hunger and thirst2 hours after interventionhunger and thirst on a visual analogue scale from 0 to 10

Countries

Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026