A Multicentre Preoperative Fasting Audit

Study Overview
=================
Brief Summary
-----------------
The new European Society of Anaesthesiology and Intensive Care (ESAIC) preoperative fasting guideline recommends a one hour minimum fasting time for clear fluids. This represents a major change in the practice of pediatric anaesthesia. During the transition to shorter fasting times on a global scale, we need a large multicenter audit to monitor the incidence of pulmonary aspiration.

Detailed Description
-----------------
The purpose of preoperative fasting is to achieve an empty stomach at the time of anaesthesia induction. Most current fasting guidelines all take into account the balance between the risk of pulmonary aspiration and the harmful effects of prolonged preoperative fasting. However, there is increased awareness among pediatric as well as general anaesthesiologists that many patients suffer from prolonged duration of fasting in spite of the reasonable nominal respective limits of 6-4-2 hours. Prolonged fasting may be harmful, especially in small children, but also in adults with a poor nutritional status. The new European Society of Anaesthesiology and Intensive Care (ESAIC, 2022) preoperative fasting guideline recommends a one-hour minimum fasting time for clear fluids. This represents a major change in the practice of paediatric anaesthesia. During the transition to shorter fasting times on a global scale, we need a large multicentre audit to monitor the incidence of pulmonary aspiration. The primary aim of the European Preoperative Fasting Audit (EUROFAST) is to determine the safety of reducing the required fasting time for clear fluids to at least one hour in children fasting before elective procedures requiring general anaesthesia (as recommended in the ESAIC guideline).

Official Title
-----------------
A Multicentre Audit of the Incidence of Pulmonary Aspiration With Different Fasting Regimens - European Preoperative Fasting Audit (EUROFAST)

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children, age < 16 years old General anesthesia Exclusion criteria Age > 15 years Procedure without general anesthesia General anesthesia performed at center with less than 1000 pediatric cases per year

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 15 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 6-4-2 group<br>- Cases from centres implementing the rule of a minimum of 6 hours of fasting for solids, 4 hours for breast milk and 2 hours for clear fluids before anesthesia. | |
| 6-4-1 group<br>- Cases from centres implementing the 1 hour fasting rule for clear fluids recommended by ESAIC and specified in the guideline Preoperative fasting in children | |
| 6-4-0 group<br>- Cases from centres implementing the zero hour clear fasting rule, which means that children are allowed intake of clear fluids until they are called to the operating room | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary aspiration | The incidence of confirmed pulmonary aspiration according to the study protocol | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suspected pulmonary aspiration | The incidence regurgitation leading to transient desaturation that has resolved at the end of the procedure | Intraoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Preoperation fasting, General anesthesia, Children, Pulmonary aspiration of gastric contents