Low incidence of pulmonary aspiration in children allowed intake of clear fluids until called to the operating suite.
Hanna Andersson, Björn Zarén, Peter Frykholm
https://pubmed.ncbi.nlm.nih.gov/25940831/Actively Recruiting
Led by Boston Children's Hospital · Updated on 2026-04-24
288
Participants Needed
1
Research Sites
13 weeks
Total Duration
Researchers are studying children aged 13 to 17 years who are scheduled for an elective upper gastrointestinal endoscopy to understand how different volumes of clear oral fluids consumed two hours before the procedure affect the residual gastric volume. This study aims to improve fasting guidelines by evaluating the relationship between fluid intake volume and stomach content, helping to optimize preoperative fluid intake to maintain safety and comfort. The study is conducted at Boston Childrens Hospital and includes a randomized design with four groups. Participants are randomly assigned to one of four groups, each consuming a different volume of clear fluid water, pulp-free juice, or teacoffee without milk at two hours before surgery 3 mlkg, 5 mlkg, 7 mlkg, or 10 mlkg. The study plans to enroll 288 patients in total, with 72 in each group. During the upper GI endoscopy, the actual volume and acidity pH of stomach contents will be measured by suctioning the stomach contents. During the study day, researchers will collect demographic data, vital signs, and details about the endoscopy procedure from each participant. The primary outcome is the gastric volume measured from arrival until discharge from the post-anesthesia care unit, up to 24 hours. Secondary outcomes include gastric pH and the incidence of pulmonary aspiration. This information will help establish better fasting guidelines to improve patient hydration and safety before anesthesia.
CONDITIONS
Comparison of Residual Gastric Volume Between Children Who Drink Different Clear Oral Fluid Volume
S
Sirirat Rattanaarpa, MD
P
Patcharee Sriswasdi, MD, MPH
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Boston Children's Hospital
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | 3 ml/kg Clear Oral Fluid | 5 ml/kg Clear Oral Fluid | 7 ml/kg Clear Oral Fluid | 10 ml/kg Clear Oral Fluid | Guideline-Recommended Clear Fluid Fasting |
|---|---|---|---|---|---|
| What it is | Children receive 3 ml/kg of clear oral fluid (water, pulp-free juice, or tea/coffee without milk) before elective upper GI endoscopy. | Children receive 5 ml/kg of clear oral fluid by mouth before elective endoscopy. | Children receive 7 ml/kg of clear oral fluid prior to elective endoscopy. | Children receive 10 ml/kg of clear oral fluid before elective endoscopy. | Guidelines recommend clear oral fluid intake up to 10 ml/kg, with a minimum fasting period of 2 hours before elective pediatric procedures. |
| Role in trial | Randomized intervention arm to test impact of 3 ml/kg fluid volume on gastric volume and safety metrics in eligible children. | Randomized intervention arm to study effect of 5 ml/kg fluid volume before endoscopy. | Randomized arm; evaluates 7 ml/kg fluid intake as part of pre-procedure gastric volume study. | Randomized arm to investigate safety and gastric volume after 10 ml/kg fluid intake pre-endoscopy. | Defines the recommended pediatric preoperative fasting protocol for clear fluids, used as reference for safety and feasibility evaluation. |
| Primary use | Assesses residual gastric volume and safety after low-volume clear oral fluid intake pre-endoscopy. | Measures gastric volume following moderate fluid intake to compare safety and aspiration risk before surgery. | Examines gastric volume and aspiration risk after higher-volume fluid intake pre-procedure. | Tests safety, gastric volume, and aspiration risk following the largest fluid volume permitted in this study. | Guideline establishes evidence-based safe fluid volumes and minimum fasting period for children to minimize risk of aspiration and optimize gastric emptying. |
| How it is given or performed | Clear oral fluid administered by mouth; volume calculated as 3 ml/kg body weight. Intake occurs before endoscopy as per study protocol. | Clear oral fluid provided by mouth, at 5 ml/kg based on patient weight, prior to procedure. | Patients drink clear oral fluid, calculated as 7 ml/kg before scheduled endoscopy. | Children receive 10 ml/kg clear oral fluid by mouth before elective endoscopy, administered as per weight. | Guidelines recommend clear fluids by mouth, up to 10 ml/kg, allowed for children up to 2 hours before anesthesia for elective procedures. |
| Evidence status | Results for residual gastric volume and aspiration risk are not yet available. Study completion expected in late 2027. | No published results are available yet for safety and gastric volume outcomes at 5 ml/kg in this study population. | Trial results for gastric emptying and risk of aspiration at 7 ml/kg intake are not yet published. | Results regarding safety and gastric volume after 10 ml/kg intake remain unavailable pending trial completion. | Large guideline reviews and prospective studies indicate low risk of pulmonary aspiration and safe gastric emptying when children are allowed clear fluids up to 10 ml/kg at least 2 hours before elective procedures. |
| Important limitations | Results regarding gastric volume and aspiration risk are not established, so clinical recommendations cannot be made until trial completion. Evidence will be limited to children in defined elective endoscopy settings. | Results pending; factors such as emergency procedures and non-endoscopy surgery populations may limit applicability. | Current data unavailable. Trial results will not apply to patients with GI motility disorders, emergency surgery, or outside age range. | No published outcomes yet. Study population excludes children with gastric motility issues or emergent procedures. | Guidelines are based on aggregate evidence and may not address specific surgical scenarios, certain high-risk populations, or rare GI motility disorders. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 hours (before procedure)
Participants drink a specified volume of clear oral fluid (3, 5, 7, or 10 ml/kg) 2 hours before their scheduled elective esophago-gastro-duodenoscopy (EGD) procedure.
1 baseline visit on the day of surgery
Duration - Up to 24 hours
Participants are monitored from arrival on the day of surgery until discharge from the post-anesthesia care unit (PACU) for up to 24 hours to measure gastric volume, gastric pH, and incidence of pulmonary aspiration.
Continuous monitoring during hospital stay on surgery day
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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Lead Sponsor