A Multicentre Preoperative Fasting Audit

NCT05519969 | Completed

• 1 other identifier: EUROFAST
• Study Type: observational
• Target: 307,162
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Aspiration of Gastric Contents

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Pulmonary aspiration

  The incidence of confirmed pulmonary aspiration according to the study protocol

  Intraoperative

Secondary Outcomes (1)

• Suspected pulmonary aspiration

  Intraoperative

Study Arms (3)

6-4-2 group

\- 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

\- 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

\- 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

Eligibility Criteria

• Age: 0 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children less than 16 years old

You may qualify if:

• Children, age \< 16 years old
• General anesthesia

You may not qualify if:

• Age \> 15 years
• Procedure without general anesthesia
• General anesthesia performed at center with less than 1000 pediatric cases per year

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (1)

Uppsala University Hospital

Uppsala, 75185, Sweden

Location

Related Links

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

MeSH Terms

Conditions

Respiratory Aspiration of Gastric Contents

Condition Hierarchy (Ancestors)

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

Study Officials

• Peter Frykholm, MD, PhD

  Uppsala University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 29, 2022
• Study Start: January 2, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: From ethics approval to Dec. 31, 2023
• Access Criteria: Official web page

Locations

SE (1)