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

Uppsala University Hospital

Status: Enrolling

Conditions: Pulmonary Aspiration of Gastric Contents

Treatments: Procedure: Preoperative fasting instruction

Study type: Interventional

Funder types: Other

Identifiers

NCT05695066

ENGUS

Details and patient eligibility

About

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 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 6 months to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 2 patient groups

4H group

Experimental group

Description:

Patients parents instructed to stop enteral feeding 4 hours before predicted anesthesia induction

Treatment:

Procedure: Preoperative fasting instruction

6H group

Active Comparator group

Description:

Patients parents instructed to stop enteral feeding 6 hours before predicted anesthesia induction

Treatment:

Procedure: Preoperative fasting instruction