Skip to content

Gastric Content After 6 vs 4 Hours of Preoperative Fasting in Children

Gastric Content After 6 vs 4 Hours of Preoperative Fasting in Children on Enteral Nutrition. A Randomized Controlled Trial Using Gastric Ultrasound

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05695066
Acronym
ENGUS
Enrollment
180
Registered
2023-01-23
Start date
2023-01-23
Completion date
2025-10-31
Last updated
2024-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Aspiration of Gastric Contents

Keywords

Preoperation fasting, Anaesthesia, Children, Enteral feeding

Brief summary

The primary objective of the study is to compare the risk of increased stomach contents after tube feeding (Enteral feeding) 6 and 4 hours before anesthesia using antrum measured by ultrasound.

Detailed description

Children must fast for a certain period of time before anesthesia and surgery to reduce the risk of food residues being vomited up and ending up in the trachea (so-called aspiration). But there are disadvantages to fasting for a long time before an operation, for example the blood sugar level can drop and the body can become dehydrated. Small children risk such side effects to a greater degree than adults, and therefore international work is underway to revise the rules for fasting before surgery. Enteral feeding children are a special risk group because they are usually completely dependent on tube feeding for nutrition and fluid intake.

Interventions

PROCEDUREPreoperative fasting instruction

Patients parents instructed to stop enteral feeding at a specified time before predicted anesthesia induction

Sponsors

Uppsala University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

Computerized randomization. Randomization outcome distributed via sealed envelopes. Randomization key stored on secure server.

Intervention model description

Randomized controlled trial.

Eligibility

Sex/Gender
ALL
Age
6 Months to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
CSAImmediately before anesthesia inductionGastric antral surface area

Secondary

MeasureTime frameDescription
Suctioned GCVImmediately after intubationGastric content volume suctioned through nasogastric tube after induction

Countries

Sweden

Contacts

Primary ContactPeter Frykholm, MD, PhD
peter.frykholm@surgsci.uu.se+46186171240
Backup ContactAli-Reza Modiri, PhD
ali-reza.modiri@uu.se+46727411410

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026