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

Not Applicable

Recruiting

• Conditions: Pulmonary Aspiration of Gastric Contents
• Interventions: Procedure: Preoperative fasting instruction

• Registration Number: NCT05695066
• Lead Sponsor: Uppsala University Hospital

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.

Study Timeline

• Study First Submitted: 2023-01-12
• Study First Submitted QC: 2023-01-12
• Study Start: 2023-01-23
• Study First Posted: 2023-01-23
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-14
• Primary Completion: 2025-05
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4H group	Preoperative fasting instruction	Patients parents instructed to stop enteral feeding 4 hours before predicted anesthesia induction
6H group	Preoperative fasting instruction	Patients parents instructed to stop enteral feeding 6 hours before predicted anesthesia induction

Primary Outcome Measures

Name	Time	Method
CSA	Immediately before anesthesia induction	Gastric antral surface area

Secondary Outcome Measures

Name	Time	Method
Suctioned GCV	Immediately after intubation	Gastric content volume suctioned through nasogastric tube after induction

Trial Locations

Locations (1)

Uppsala University Hospital; 🇸🇪 Uppsala, Sweden