A Multicentre Preoperative Fasting Audit

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.

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Key information

Conditions

Pulmonary Aspiration of Gastric Contents Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Laryngopharyngeal Reflux Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Aspiration of Gastric Contents Respiratory Tract Diseases

Age range

0 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Uppsala University Hospital

Uppsala, 75185, Sweden

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Pulmonary aspiration

Time frame: Intraoperative

The incidence of confirmed pulmonary aspiration according to the study protocol

Secondary outcomes

Suspected pulmonary aspiration

Time frame: Intraoperative

The incidence regurgitation leading to transient desaturation that has resolved at the end of the procedure

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Official study title

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

Acronym: EUROFAST

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: Aug 29, 2022
Registry last updated: Jul 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed