Pulmonary Aspiration of Gastric ContentsEUROFASTNCT05519969
A Multicentre Preoperative Fasting Audit
An observational study of Pulmonary Aspiration of Gastric Contents, run by Uppsala University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 15 years
- Conditions the study is for
- Pulmonary Aspiration of Gastric Contents
- How many people
- 307,162 participants
- Where
- 1 siteSweden
- Study dates
- 2 Jan 2023to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Children less than 16 years old
Who may be able to join
- Children, age < 16 years old
- General anesthesia
Who cannot join
- Age > 15 years
- Procedure without general anesthesia
- General anesthesia performed at center with less than 1000 pediatric cases per year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentre Audit of the Incidence of Pulmonary Aspiration With Different Fasting Regimens - European Preoperative Fasting Audit (EUROFAST)
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.
Read the 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).
- Conditions
- Pulmonary Aspiration of Gastric Contents
- Keywords
- Preoperation fasting, General anesthesia, Children, Pulmonary aspiration of gastric contents
- Medical subject headings
- Respiratory Aspiration of Gastric Contents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary aspiration
The incidence of confirmed pulmonary aspiration according to the study protocol
Measured: Intraoperative
Secondary outcomes (1)
Suspected pulmonary aspiration
The incidence regurgitation leading to transient desaturation that has resolved at the end of the procedure
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start2 Jan 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Aspiration of Gastric ContentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 307,162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Frykholm, Uppsala University
- Investigators
- Peter Frykholm, MD, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05519969
- Sponsor's protocol ID
- EUROFAST
- Acronym
- EUROFAST
- Status last verified
- Jul 2024
- First submitted
- 22 Aug 2022
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan to share data on request.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Audit of the Incidence of Pulmonary Aspiration With Different Fasting Regimens - European Preoperative Fasting Audit (EUROFAST)
- ClinicalTrials.gov ID
- NCT05519969
- Acronym / sponsor ID
- EUROFAST / EUROFAST
- Conditions
- Pulmonary Aspiration of Gastric Contents
- Keywords
- Preoperation fasting, General anesthesia, Children, Pulmonary aspiration of gastric contents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 307,162 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 29 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 0 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children less than 16 years old
Key inclusion criteria (2 listed)
- Children, age < 16 years old
- General anesthesia
Key exclusion criteria (3 listed)
- Age > 15 years
- Procedure without general anesthesia
- General anesthesia performed at center with less than 1000 pediatric cases per year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pulmonary aspiration
Time frame: Intraoperative
The incidence of confirmed pulmonary aspiration according to the study protocol
1 secondary outcome
Suspected pulmonary aspiration
Time frame: Intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Pre-operative fasting in children: guideline from the European Society of Anaesthesiology and Intensive Care.Link provided by the sponsor.
- Low incidence of pulmonary aspiration in children allowed intake of clear fluids until called to the operating suiteLink provided by the sponsor.
- Impact of clear fluid fasting on pulmonary aspiration in children undergoing general anesthesia: Results of the German prospective multicenter observational (NiKs) studyLink provided by the sponsor.
- Using quality improvement methods to reduce clear fluid fasting times in children on a preoperative wardLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Plan to share data on request.
Related trials for Pulmonary Aspiration of Gastric Contents
Recruiting
Protective Benefits of a Clear Liquid Diet on Residual Gastric Content in Patients Taking Glucagon Like Peptide-1 Receptor (GLP-1 RA) Agonist Prior to Anesthesia
Pulmonary Aspiration
Enrolling by invitationObservational study
Effect of Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RA) on Gastric Emptying
Gastric Emptying, Glucagon-Like Peptide-1 Receptor Agonists
Recruiting
Effect of Fasting Recommendations Among Patients Using GLP-1 Receptor Agonists
Residual Gastric Contents, Pulmonary Aspiration of Gastric Contents
Active, not recruiting
Sonographic Assessment of Cricoid Pressure
Aspiration; Gastric Contents, Anesthesia, Intubation Complication
RecruitingObservational study
The Million Anesthesia Cases Study (MACS) - a Cohort Study of Preoperative Fasting and Perioperative Outcomes
Anesthesia, Sedation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Frykholm, MD, PhD principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Aspiration of Gastric Contents, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary aspiration (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024.