Gastric Volume After Water or Jelly Ingestion

NCT05737641 | Completed

• 1 other identifier: CES 48_2022
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• gastric antral cross-sectional area

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

  2 hours after intervention

Secondary Outcomes (4)

• gastric volume

  2 hours after intervention

• gastric volume greater than 1.5 mL/Kg

  2 hours after intervention

• Qualitative gastric evaluation

  2 hours after intervention

• hunger and thirst

  2 hours after intervention

Study Arms (2)

water ingestion

ACTIVE COMPARATOR

Ingestion of 102 mL of fresh water

Other: water ingestion

jelly ingestion

EXPERIMENTAL

ingestion of 100 gr strawberry jelly

Dietary Supplement: jelly ingestion

Interventions

water ingestion OTHER

ingestion of water after an 8h-fasting period

water ingestion

jelly ingestion DIETARY_SUPPLEMENT

ingestion of jelly after an 8h-fasting period

jelly ingestion

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult volunteers working in the hospital Centro Hospitalar de Entre o Douro e Vouga (CHEDV)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro Hospitalar de Entre o Douro e Vouga: lead

Study Sites (1)

Centro Hospitalar de Entre Douro e Vouga (CHEDV)

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

Location

MeSH Terms

Conditions

Fasting; Gastroesophageal Reflux; Pneumonia, Aspiration

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pneumonia; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Paulo Correia

Model Details: RCT crossover study

Study Record Dates

• First Submitted: December 23, 2022
• First Posted: February 21, 2023
• Study Start: December 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: August 25, 2024
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)