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A Multicentre Preoperative Fasting Audit (EUROFAST)

U

Uppsala University

Status

Completed

Conditions

Pulmonary Aspiration of Gastric Contents

Study type

Observational

Funder types

Other

Identifiers

NCT05519969
EUROFAST

Details and patient eligibility

About

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.

Full 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).

Enrollment

307,162 patients

Sex

All

Ages

Under 15 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

307,162 participants in 3 patient groups

6-4-2 group
Description:
- 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
Description:
- 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
Description:
- 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

Trial contacts and locations

1

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Central trial contact

Peter Frykholm, MD, PhD; Ali-Reza Modiri, PhD

Data sourced from clinicaltrials.gov

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