Ignite Creation Date:
2024-05-06 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05737641
Status:
COMPLETED
Last Update Posted:
2024-04-22
First Post:
2022-12-23
Brief Title:
Gastric Volume After Water or Jelly Ingestion
Sponsor:
Centro Hospitalar de Entre o Douro e Vouga
Organization:
Centro Hospitalar de Entre o Douro e Vouga
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 15 mLkg 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
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 15 mLkg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None