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

Overview

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.

Full Title of Study: “Gastric Content After 6 vs 4 Hours of Preoperative Fasting in Children on Enteral Nutrition. A Randomized Controlled Trial Using Gastric Ultrasound”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Prevention
  • Masking: Double (Investigator, Outcomes Assessor)
• Study Primary Completion Date: December 30, 2024

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

• Procedure: Preoperative fasting instruction
  • Patients parents instructed to stop enteral feeding at a specified time before predicted anesthesia induction

Arms, Groups and Cohorts

• Experimental: 4H group
  • Patients parents instructed to stop enteral feeding 4 hours before predicted anesthesia induction
• Active Comparator: 6H group
  • Patients parents instructed to stop enteral feeding 6 hours before predicted anesthesia induction

Clinical Trial Outcome Measures

Primary Measures

• CSA
  • Time Frame: Immediately before anesthesia induction
  • Gastric antral surface area

Secondary Measures

• Suctioned GCV
  • Time Frame: Immediately after intubation
  • Gastric content volume suctioned through nasogastric tube after induction

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: 12 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Uppsala University Hospital
• Provider of Information About this Clinical Study
  • Principal Investigator: Peter Frykholm, Associate professor – Uppsala University Hospital
• Overall Official(s)
  • Peter Frykholm, MD PhD, Principal Investigator, Uppsala University Hospital
• Overall Contact(s)
  • Peter Frykholm, MD, PhD, +46186171240, peter.frykholm@surgsci.uu.se