Gastric Emptying After a Yoghurt Breakfast in Children: a Pilot Study
ConditionPreoperative Fasting
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-10
SponsorBaskent University Ankara Hospital
About this trial
Children are asked to fast before anaesthesia to reduce the amount of material remaining in the stomach. Prolonged fasting can cause hunger, thirst and discomfort. Although shorter fasting intervals have been introduced for clear fluids and breast milk, less is known about how quickly a light yoghurt breakfast leaves the stomach. Yoghurt differs from clear fluids in its nutrient content and semi-solid consistency.
The primary aim of this study is to compare gastric emptying after three versus four hours of fasting following yoghurt intake in 24 children aged 1 to 10 years undergoing elective upper gastrointestinal endoscopy under anaesthesia at Baskent University Faculty of Medicine Ankara Hospital. Children will be randomly allocated to two equal groups. They may eat yoghurt freely up to a maximum of 150 g; there is no prescribed fixed or weight-based dose, and the amount actually eaten will be recorded.
Ultrasound will assess stomach contents at the assigned fasting interval. If the stomach has not emptied according to the study criterion, the assessment will be repeated at 10-minute intervals before proceeding with anaesthesia. Gastric contents will also be assessed directly during endoscopy. The clinicians performing ultrasound and endoscopy will not know the assigned group; the anaesthetist will know it.
The primary outcome is the proportion of children with an empty stomach at the first ultrasound assessment, compared between the three-hour and four-hour groups. The primary hypothesis is that a three-hour interval after yoghurt intake will yield a similar proportion of empty stomachs to a four-hour interval. Secondary outcomes include estimated gastric volume, endoscopic findings, hunger, and agreement between ultrasound and endoscopic assessment.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 1 to 10 years.
Scheduled for elective upper gastrointestinal endoscopy under anaesthesia at Baskent University Faculty of Medicine Ankara Hospital.
American Society of Anesthesiologists physical status I or II.
Written informed consent from a parent or legal guardian following detailed study information.
Disqualifiers
Cardiac disease or dysfunction.
Respiratory disease or dysfunction.
Peripheral circulatory disorder.
Diabetes mellitus.
Trial design
Design model
Parallel
Treatments tested in this trial
Three-hour fasting after yoghurt breakfast
Other interventionAd libitum oral intake of yoghurt, capped at 150 g, followed by a planned three-hour fasting interval before the first gastric ultrasound examination. There is no predetermined fixed or weight-based dose. The quantity actually consumed and actual fasting interval will be recorded.
Four-hour fasting after yoghurt breakfast
Other interventionAd libitum oral intake of yoghurt, capped at 150 g, followed by a planned four-hour fasting interval before the first gastric ultrasound examination. There is no predetermined fixed or weight-based dose. The quantity actually consumed and actual fasting interval will be recorded.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Three-hour fastingExperimental treatment 1 intervention
Group B: Four-hour fastingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of children with an empty stomach on the first gastric ultrasound assessment
The primary comparison is between the randomized three-hour and four-hour fasting groups after yoghurt intake. Number and proportion of children with ultrasound-estimated gastric content volume below 1.5 mL/kg at the first examination after the allocated fasting interval. The estimate is calculated from antral cross-sectional area using GCV (mL/kg) = 0.0093 x CSA (mm2) - 0.96. The first examination will determine this outcome even if subsequent scans show emptying after additional waiting.
Time frame
At the first ultrasound assessment, 3 or 4 hours after yoghurt ingestion according to randomized allocation, on the procedure day.Secondary outcomes
1
Ultrasound-estimated gastric volume at the first assessment
Weight-indexed gastric content volume, expressed in mL/kg, estimated at the first ultrasound assessment using GCV = 0.0093 x antral CSA (mm2) - 0.96. Antral diameters are measured in triplicate in the right lateral decubitus position. Lower values indicate a smaller estimated residual volume.
Time frame
At the first ultrasound assessment, 3 or 4 hours after yoghurt ingestion, on the procedure day.2
Proportion of children with an empty stomach on endoscopic assessment
Number and proportion of children classified as having an empty stomach on direct endoscopic inspection. An empty stomach is defined as no visible contents or only a non-aspirable trace; visible residual material beyond this trace is classified as non-empty. The nature and quantity of any residual contents will be documented. Endoscopy follows the ultrasound-guided decision to proceed, including additional waiting when required.
Time frame
During upper gastrointestinal endoscopy on the same procedure day, after ultrasound assessment.3
Residual gastric content volume recorded during endoscopy
Quantity of gastric contents recorded during endoscopy, expressed in mL when measured by aspiration. The presence and character of residual contents will also be documented. A missing or unmeasured volume will not be assumed to be zero.
Time frame
During upper gastrointestinal endoscopy on the procedure day, after the ultrasound-guided decision to proceed.4
Agreement between ultrasound and endoscopic empty or full classifications
Observed agreement and Cohen's kappa, where estimable, between categorical gastric ultrasound and endoscopic assessments. Assessment times and any repeat scans will be recorded. Interpretation will account for the interval between assessments and for the requirement to meet the ultrasound empty-stomach criterion before induction; the endoscopic sample may consequently contain predominantly ultrasound-empty observations.
Time frame
Paired ultrasound and endoscopic assessments during the same procedure-day visit.Sponsors and contacts
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Source ClinicalTrials.gov
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