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

Study Overview
=================
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.

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

Conditions
-----------------
Pulmonary Aspiration of Gastric Contents

Intervention / Treatment
-----------------
* Procedure: Preoperative fasting instruction


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 4H group<br>Patients parents instructed to stop enteral feeding 4 hours before predicted anesthesia induction | Procedure: Preoperative fasting instruction<br>* Patients parents instructed to stop enteral feeding at a specified time before predicted anesthesia induction<br>|
| Active Comparator: 6H group<br>Patients parents instructed to stop enteral feeding 6 hours before predicted anesthesia induction | Procedure: Preoperative fasting instruction<br>* Patients parents instructed to stop enteral feeding at a specified time before predicted anesthesia induction<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CSA | Gastric antral surface area | Immediately before anesthesia induction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suctioned GCV | Gastric content volume suctioned through nasogastric tube after induction | Immediately after intubation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Preoperation fasting, Anaesthesia, Children, Enteral feeding