A Multicentre Preoperative Fasting Audit (EUROFAST)

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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Aspiration of Gastric Contents

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).

• Study Type: Observational
• Enrollment (Actual): 307162

Contacts and Locations

Study Locations

• Sweden
  • Uppsala, Sweden, 75185
    • Uppsala University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 15 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Children less than 16 years old

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
6-4-2 group; - 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; - 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; - 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

Collaborators and Investigators

• Sponsor: Uppsala University
• Investigators: Principal Investigator: Peter Frykholm, MD, PhD, Uppsala University

Publications and helpful links

Helpful Links

• Pre-operative fasting in children: guideline from the European Society of Anaesthesiology and Intensive Care.
• Low incidence of pulmonary aspiration in children allowed intake of clear fluids until called to the operating suite
• Impact of clear fluid fasting on pulmonary aspiration in children undergoing general anesthesia: Results of the German prospective multicenter observational (NiKs) study
• Using quality improvement methods to reduce clear fluid fasting times in children on a preoperative ward

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2023
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: August 22, 2022
• First Submitted That Met QC Criteria: August 26, 2022
• First Posted (Actual): August 29, 2022

Study Record Updates

• Last Update Posted (Actual): July 17, 2024
• Last Update Submitted That Met QC Criteria: July 16, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Children; General anesthesia; Preoperation fasting; Pulmonary aspiration of gastric contents
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux; Laryngopharyngeal Reflux; Respiratory Aspiration; Respiratory Aspiration of Gastric Contents
• Other Study ID Numbers: EUROFAST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Plan to share data on request.
• IPD Sharing Time Frame: From ethics approval to Dec. 31, 2023
• IPD Sharing Access Criteria: Official web page
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No