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A Multicentre Preoperative Fasting Audit

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05519969
Acronym
EUROFAST
Enrollment
307162
Registered
2022-08-29
Start date
2023-01-02
Completion date
2023-12-31
Last updated
2024-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Aspiration of Gastric Contents

Keywords

Preoperation fasting, General anesthesia, Children, Pulmonary aspiration of gastric contents

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).

Interventions

None listed

Sponsors

Uppsala University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Years to 15 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pulmonary aspirationIntraoperativeThe incidence of confirmed pulmonary aspiration according to the study protocol

Secondary

MeasureTime frameDescription
Suspected pulmonary aspirationIntraoperativeThe incidence regurgitation leading to transient desaturation that has resolved at the end of the procedure

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026