Pulmonary Aspiration of Gastric ContentsENGUSNCT05695066
Gastric Content After 6 vs 4 Hours of Preoperative Fasting in Children
A study testing Preoperative fasting instruction in people with Pulmonary Aspiration of Gastric Contents, run by Uppsala University Hospital at 1 site in Sweden.
Trial summary
The primary objective of the study is to compare the risk of increased stomach contents after tube feeding (Enteral feeding) 6 and 4 hours before anesthesia using antrum measured by ultrasound. Read more about this study
- Who is it for?
- Ages 6 months to 12 years
- Conditions the study is for
- Pulmonary Aspiration of Gastric Contents
- What is being tested?
- Preoperative fasting instruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSweden
- Study dates
- 23 Jan 2023to Oct 2025
- Phase
- Interventional
- 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 6 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child on intermittent or continuous enteral nutrition, scheduled for elective procedure requiring general anesthesia
Who cannot join
- Moderate to severe gastrointestinal motility disorder Emergency surgery Anatomical risk factor for pulmonary aspiration such as achalasia or bowel obstruction Parents cannot understand study information due to language barrier
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Uppsala University Hospital
Uppsala, 75185
Peter Frykholm, MD PhD, +46708454969, peter.frykholm@surgsci.uu.se
Ali Modiri, PhD, +467411410, alireza.modiri@akademiska.se
About this study
Official title: Gastric Content After 6 vs 4 Hours of Preoperative Fasting in Children on Enteral Nutrition. A Randomized Controlled Trial Using Gastric Ultrasound
The primary objective of the study is to compare the risk of increased stomach contents after tube feeding (Enteral feeding) 6 and 4 hours before anesthesia using antrum measured by ultrasound.
Read the detailed description
Children must fast for a certain period of time before anesthesia and surgery to reduce the risk of food residues being vomited up and ending up in the trachea (so-called aspiration). But there are disadvantages to fasting for a long time before an operation, for example the blood sugar level can drop and the body can become dehydrated. Small children risk such side effects to a greater degree than adults, and therefore international work is underway to revise the rules for fasting before surgery.
Enteral feeding children are a special risk group because they are usually completely dependent on tube feeding for nutrition and fluid intake.
- Conditions
- Pulmonary Aspiration of Gastric Contents
- Being tested
- Preoperative fasting instruction
- Keywords
- Preoperation fasting, Anaesthesia, Children, Enteral feeding
- 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.
Preoperative fasting instructionProcedure or surgery
Patients parents instructed to stop enteral feeding at a specified time before predicted anesthesia induction
| Study group | Role | What they receive |
|---|---|---|
| 4H group | Experimental | Patients parents instructed to stop enteral feeding 4 hours before predicted anesthesia induction Receives: Procedure: Preoperative fasting instruction |
| 6H group | Active comparator | Patients parents instructed to stop enteral feeding 6 hours before predicted anesthesia induction Receives: Procedure: Preoperative fasting instruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
CSA
Gastric antral surface area
Measured: Immediately before anesthesia induction
Secondary outcomes (1)
Suctioned GCV
Gastric content volume suctioned through nasogastric tube after induction
Measured: Immediately after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start23 Jan 2023
- Primary completionMay 2025 (estimated)
- Study completionOct 2025 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Frykholm, Uppsala University Hospital
- Investigators
- Peter Frykholm, MD PhD, Principal investigator, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05695066
- Sponsor's protocol ID
- ENGUS
- Acronym
- ENGUS
- Status last verified
- May 2024
- First submitted
- 12 Jan 2023
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Content After 6 vs 4 Hours of Preoperative Fasting in Children on Enteral Nutrition. A Randomized Controlled Trial Using Gastric Ultrasound
- ClinicalTrials.gov ID
- NCT05695066
- Acronym / sponsor ID
- ENGUS / ENGUS
- Conditions
- Pulmonary Aspiration of Gastric Contents
- Keywords
- Preoperation fasting, Anaesthesia, Children, Enteral feeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Uppsala University HospitalUniversity, hospital or other
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 23 Jan 2023 (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 primary objective of the study is to compare the risk of increased stomach contents after tube feeding (Enteral feeding) 6 and 4 hours before anesthesia using antrum measured by ultrasound.
Detailed description
Children must fast for a certain period of time before anesthesia and surgery to reduce the risk of food residues being vomited up and ending up in the trachea (so-called aspiration). But there are disadvantages to fasting for a long time before an operation, for example the blood sugar level can drop and the body can become dehydrated. Small children risk such side effects to a greater degree than adults, and therefore international work is underway to revise the rules for fasting before surgery.
Enteral feeding children are a special risk group because they are usually completely dependent on tube feeding for nutrition and fluid intake.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| 4H group | Experimental | Procedure: Preoperative fasting instructionPatients parents instructed to stop enteral feeding 4 hours before predicted anesthesia induction |
| 6H group | Active comparator | Procedure: Preoperative fasting instructionPatients parents instructed to stop enteral feeding 6 hours before predicted anesthesia induction |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Child on intermittent or continuous enteral nutrition, scheduled for elective procedure requiring general anesthesia
Key exclusion criteria (1 listed)
- Moderate to severe gastrointestinal motility disorder Emergency surgery Anatomical risk factor for pulmonary aspiration such as achalasia or bowel obstruction Parents cannot understand study information due to language barrier
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative fasting instructionPatients parents instructed to stop enteral feeding at a specified time before predicted anesthesia induction | Procedure or surgery | 4H group, 6H group |
Primary outcome
CSA
Time frame: Immediately before anesthesia induction
Gastric antral surface area
1 secondary outcome
Suctioned GCV
Time frame: Immediately after intubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Pre-operative fasting in children: A guideline from the European Society of Anaesthesiology and Intensive CareLink provided by the sponsor.
- Ultrasound assessment of gastric emptying time after a standardised light breakfast in healthy children: A prospective observational study.Link provided by the sponsor.
- Gastric content assessed with gastric ultrasound in paediatric patients prescribed a light breakfast prior to general anaesthesia: A prospective observational study.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Pulmonary Aspiration of Gastric Contents
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Effect of Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RA) on Gastric Emptying
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Effect of Fasting Recommendations Among Patients Using GLP-1 Receptor Agonists
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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 Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative fasting instruction in people with Pulmonary Aspiration of Gastric Contents, run by Uppsala University Hospital 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Frykholm, MD, PhD (+46186171240, peter.frykholm@surgsci.uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CSA (time frame: Immediately before anesthesia induction). 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 14 May 2024.