Gastric Volume After Oral Ingestion of Water or Jelly in Volunteers
Primary Purpose
Fasting, Surgery, Ultrasound Therapy; Complications
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
water ingestion
jelly ingestion
Sponsored by
About this trial
This is an interventional prevention trial for Fasting focused on measuring Preoperative Fasting, Elective Surgery, Ultrasound, Gastric Volume, Jelly, regurgitation, Aspiration pneumonia
Eligibility Criteria
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
Sites / Locations
- Centro Hospitalar de Entre Douro e Vouga (CHEDV)
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
water ingestion
jelly ingestion
Arm Description
Ingestion of 102 mL of fresh water
ingestion of 100 gr strawberry jelly
Outcomes
Primary Outcome Measures
gastric antral cross-sectional area
antral cross-sectional area measured by ultrasound in lateral decubitus
Secondary Outcome Measures
gastric volume
gastric volume calculated by the formula of Perlas et al
gastric volume greater than 1.5 mL/Kg
number of participants with gastric volume greater than 1.5 mL/kg
Qualitative gastric evaluation
Empty, clear fluid or solid
hunger and thirst
hunger and thirst on a visual analogue scale from 0 to 10
Full Information
NCT ID
NCT05737641
First Posted
December 23, 2022
Last Updated
February 20, 2023
Sponsor
Centro Hospitalar de Entre o Douro e Vouga
1. Study Identification
Unique Protocol Identification Number
NCT05737641
Brief Title
Gastric Volume After Oral Ingestion of Water or Jelly in Volunteers
Official Title
Ultrasonographic Evaluation of Gastric Content and Volume After Oral Ingestion of Water or Jelly in Volunteers - A Crossover Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Hospitalar de Entre o Douro e Vouga
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fasting, Surgery, Ultrasound Therapy; Complications, Aspiration Pneumonia Due to Regurgitated Food
Keywords
Preoperative Fasting, Elective Surgery, Ultrasound, Gastric Volume, Jelly, regurgitation, Aspiration pneumonia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
Outcomes Assessor
Allocation
Randomized
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
water ingestion
Arm Type
Placebo Comparator
Arm Description
Ingestion of 102 mL of fresh water
Arm Title
jelly ingestion
Arm Type
Active Comparator
Arm Description
ingestion of 100 gr strawberry jelly
Intervention Type
Other
Intervention Name(s)
water ingestion
Intervention Description
ingestion of water after an 8h-fasting period
Intervention Type
Dietary Supplement
Intervention Name(s)
jelly ingestion
Intervention Description
ingestion of jelly after an 8h-fasting period
Primary Outcome Measure Information:
Title
gastric antral cross-sectional area
Description
antral cross-sectional area measured by ultrasound in lateral decubitus
Time Frame
2 hours after intervention
Secondary Outcome Measure Information:
Title
gastric volume
Description
gastric volume calculated by the formula of Perlas et al
Time Frame
2 hours after intervention
Title
gastric volume greater than 1.5 mL/Kg
Description
number of participants with gastric volume greater than 1.5 mL/kg
Time Frame
2 hours after intervention
Title
Qualitative gastric evaluation
Description
Empty, clear fluid or solid
Time Frame
2 hours after intervention
Title
hunger and thirst
Description
hunger and thirst on a visual analogue scale from 0 to 10
Time Frame
2 hours after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Centro Hospitalar de Entre Douro e Vouga (CHEDV)
City
Santa Maria da Feira
State/Province
Aveiro
ZIP/Postal Code
4520-211
Country
Portugal
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Gastric Volume After Oral Ingestion of Water or Jelly in Volunteers
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