Gastric Volume After Oral Ingestion of Water or Jelly in Volunteers

Sponsor

Centro Hospitalar de Entre o Douro e Vouga (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05737641

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Fasting Surgery Ultrasound Therapy; Complications Aspiration Pneumonia Due to Regurgitated Food	Other: water ingestion Dietary Supplement: jelly ingestion	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention 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.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 (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Placebo Comparator: water ingestion

Ingestion of 102 mL of fresh water

Other: water ingestion

ingestion of water after an 8h-fasting period

Active Comparator: jelly ingestion

ingestion of 100 gr strawberry jelly

Dietary Supplement: jelly ingestion

ingestion of jelly after an 8h-fasting period

Outcome Measures

Primary Outcome Measures

gastric antral cross-sectional area [2 hours after intervention]
antral cross-sectional area measured by ultrasound in lateral decubitus

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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