A Multicentre Preoperative Fasting Audit

Completed

• Conditions: Pulmonary Aspiration of Gastric Contents

• Registration Number: NCT05519969
• Lead Sponsor: Uppsala University

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).

Study Timeline

• Study First Submitted: 2022-08-22
• Study First Submitted QC: 2022-08-26
• Study First Posted: 2022-08-29
• Study Start: 2023-01-02
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-16
• Last Update Posted: 2024-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 307162

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pulmonary aspiration	Intraoperative	The incidence of confirmed pulmonary aspiration according to the study protocol

Secondary Outcome Measures

Name	Time	Method
Suspected pulmonary aspiration	Intraoperative	The incidence regurgitation leading to transient desaturation that has resolved at the end of the procedure

Trial Locations

Locations (1)

Uppsala University Hospital; 🇸🇪 Uppsala, Sweden