A Multicentre Preoperative Fasting Audit

Pulmonary Aspiration of Gastric Contents Clinical Trial

— EUROFAST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05519969
• Other study ID #: EUROFAST
• Status: Recruiting
• Start date: January 2, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: January 2023
• Source: Uppsala University
• Contact: Peter Frykholm, MD, PhD
• Phone: +46186171240
• Email: peter.frykholm[@]surgsci.uu.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180000
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Pulmonary Aspiration of Gastric Contents
• Respiratory Aspiration of Gastric Contents

Locations

Country	Name	City	State
Sweden	Uppsala University Hospital	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary aspiration	The incidence of confirmed pulmonary aspiration according to the study protocol	Intraoperative
Secondary	Suspected pulmonary aspiration	The incidence regurgitation leading to transient desaturation that has resolved at the end of the procedure	Intraoperative

External Links

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