FastingNCT05737641
Gastric Volume After Water or Jelly Ingestion
A study testing water ingestion and jelly ingestion in people with Fasting and Surgery, run by Centro Hospitalar de Entre o Douro e Vouga at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fasting, Surgery, Ultrasound Therapy; Complications
- What is being tested?
- water ingestion and jelly ingestion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Dec 2022to 25 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult volunteers working in the hospital Centro Hospitalar de Entre o Douro e Vouga (CHEDV)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Centro Hospitalar de Entre Douro e Vouga (CHEDV)
Santa Maria da Feira, Aveiro District, 4520-211
About this study
Official title: Ultrasonographic Evaluation of Gastric Content and Volume After Oral Ingestion of Water or Jelly in Volunteers - A Randomised Controlled Non-inferiority Clinical Trial
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.
Read more
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.
Read the 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.
- Conditions
- Fasting, Surgery, Ultrasound Therapy; Complications, Aspiration Pneumonia Due to Regurgitated Food
- Being tested
- water ingestion, jelly ingestion
- Keywords
- Preoperative Fasting, Elective Surgery, Ultrasound, Gastric Volume, Jelly, Regurgitation, Aspiration pneumonia
- Medical subject headings
- Fasting, Gastroesophageal Reflux, Pneumonia, Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
water ingestionOther
ingestion of water after an 8h-fasting period
jelly ingestionDietary supplement
ingestion of jelly after an 8h-fasting period
| Study group | Role | What they receive |
|---|---|---|
| water ingestion | Active comparator | Ingestion of 102 mL of fresh water Receives: Other: water ingestion |
| jelly ingestion | Experimental | ingestion of 100 gr strawberry jelly Receives: Dietary Supplement: jelly ingestion |
What is being measured
The primary outcome is the main question the study is designed to answer.
gastric antral cross-sectional area
antral cross-sectional area measured by ultrasound in right lateral decubitus position (non-inferiority test)
Measured: 2 hours after intervention
Secondary outcomes (4)
gastric volume
gastric volume calculated by the formula of Perlas et al
Measured: 2 hours after intervention
gastric volume greater than 1.5 mL/Kg
number of participants with gastric volume greater than 1.5 mL/kg
Measured: 2 hours after intervention
Qualitative gastric evaluation
Empty, fluid or solid
Measured: 2 hours after intervention
hunger and thirst
hunger and thirst on a visual analogue scale from 0 to 10
Measured: 2 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start1 Dec 2022
- Primary completion1 Jul 2023
- Study completion25 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FastingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- RCT crossover study
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar de Entre o Douro e Vouga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paulo Jorge Gomes Correia, Centro Hospitalar de Entre o Douro e Vouga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05737641
- Sponsor's protocol ID
- CES 48_2022
- Status last verified
- Aug 2024
- First submitted
- 23 Dec 2022
- Last updated
- 27 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Evaluation of Gastric Content and Volume After Oral Ingestion of Water or Jelly in Volunteers - A Randomised Controlled Non-inferiority Clinical Trial
- ClinicalTrials.gov ID
- NCT05737641
- Acronym / sponsor ID
- CES 48_2022
- Conditions
- Fasting, Surgery, Ultrasound Therapy; Complications, Aspiration Pneumonia Due to Regurgitated Food
- Keywords
- Preoperative Fasting, Elective Surgery, Ultrasound, Gastric Volume, Jelly, Regurgitation, Aspiration pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Centro Hospitalar de Entre o Douro e VougaUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 25 Aug 2024 (actual)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- RCT crossover study
| Arm | Type | Receives |
|---|---|---|
| water ingestion | Active comparator | Other: water ingestionIngestion of 102 mL of fresh water |
| jelly ingestion | Experimental | Dietary Supplement: jelly ingestioningestion of 100 gr strawberry jelly |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult volunteers working in the hospital Centro Hospitalar de Entre o Douro e Vouga (CHEDV)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| water ingestioningestion of water after an 8h-fasting period | Other | water ingestion |
| jelly ingestioningestion of jelly after an 8h-fasting period | Dietary supplement | jelly ingestion |
Primary outcome
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)
4 secondary outcomes
gastric volume
Time frame: 2 hours after intervention
gastric volume greater than 1.5 mL/Kg
Time frame: 2 hours after intervention
Qualitative gastric evaluation
Time frame: 2 hours after intervention
hunger and thirst
Time frame: 2 hours after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Fasting
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
RecruitingPhase 2
FAST for DM - Fatty Acid Supplementation Trial (FAST) for Dermatomyositis (DM)
Dermatomyositis (DM), Juvenile Dermatomyositis (JDM)
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Anaesthetic Management in Patients Undergoing Coronary Artery Bypass Grafting
Preoperative Fasting, Pulmonary Aspiration During Anesthetic Induction
Recruiting
Environmental Harm Menu Labels and Overall Dietary Quality
Food Choices
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing water ingestion and jelly ingestion in people with Fasting and Surgery, run by Centro Hospitalar de Entre o Douro e Vouga at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gastric antral cross-sectional area (time frame: 2 hours after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.