Comparing fasting times before anesthesia in children on tube feeding
Gastric Content After 6 vs 4 Hours of Preoperative Fasting in Children on Enteral Nutrition. A Randomized Controlled Trial Using Gastric Ultrasound
NA · Uppsala University Hospital · NCT05695066
This study tests whether fasting for 4 or 6 hours before anesthesia affects the stomach contents in children who are fed through a tube.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 6 Months to 12 Years |
| Sex | All |
| Sponsor | Uppsala University Hospital (other) |
| Locations | 1 site (Uppsala) |
| Trial ID | NCT05695066 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the risk of increased gastric contents in children who are tube-fed when fasting for either 4 or 6 hours prior to anesthesia. By using ultrasound to measure the antrum, researchers will assess the impact of different fasting durations on the stomach contents of these children. The study addresses the balance between minimizing aspiration risk and avoiding the negative effects of prolonged fasting, particularly in a vulnerable population that relies on enteral nutrition.
Who should consider this trial
Good fit: Ideal candidates for this study are children who are on intermittent or continuous enteral nutrition and are scheduled for elective procedures requiring general anesthesia.
Not a fit: Patients with moderate to severe gastrointestinal motility disorders or those undergoing emergency surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved fasting guidelines that enhance safety and comfort for children undergoing surgery.
How similar studies have performed: While there is ongoing international work to revise fasting guidelines, this specific comparison of fasting durations in tube-fed children is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Child on intermittent or continuous enteral nutrition, scheduled for elective procedure requiring general anesthesia Exclusion Criteria: Moderate to severe gastrointestinal motility disorder Emergency surgery Anatomical risk factor for pulmonary aspiration such as achalasia or bowel obstruction Parents cannot understand study information due to language barrier
Where this trial is running
Uppsala
- Uppsala University Hospital — Uppsala, Sweden (RECRUITING)
Study contacts
- Principal investigator: Peter Frykholm, MD PhD — Uppsala University Hospital
- Study coordinator: Peter Frykholm, MD, PhD
- Email: peter.frykholm@surgsci.uu.se
- Phone: +46186171240
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pulmonary Aspiration of Gastric Contents, Preoperation fasting, Anaesthesia, Children, Enteral feeding