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RecruitingNCT05695066ENGUSUpdated May 14, 2024

Gastric Content After 6 vs 4 Hours of Preoperative Fasting in Children

An interventional study of Preoperative fasting instruction in Pulmonary Aspiration of Gastric Contents, sponsored by Uppsala University Hospital. Recruiting at 1 site in Sweden. Open to participants aged 6 Months to 12 Years. Per ClinicalTrials.gov, last updated 2024-05-14.

Sponsored by Uppsala University Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 6 months ago, but the record still lists the study as recruiting.
  • Started Jan 2023; still recruiting 3 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
6 Months to 12 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Pulmonary Aspiration of Gastric Contents

Keywords

  • Preoperation fasting
  • Anaesthesia
  • Children
  • Enteral feeding
03

In context

Respiratory Aspiration of Gastric Contents

27 studies on the registry are indexed under Respiratory Aspiration of Gastric Contents; 6 are open to participants now.

This study's planned enrollment of 180 is above the median of 101 across 16 interventional studies indexed under Respiratory Aspiration of Gastric Contents.

Browse Respiratory Aspiration of Gastric Contents studies →

Lead sponsor

Uppsala University Hospital is the lead sponsor of 73 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Child on intermittent or continuous enteral nutrition, scheduled for elective procedure requiring general anesthesia

Exclusion criteria

Exclusion Criteria:

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

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    4H group

    Patients parents instructed to stop enteral feeding 4 hours before predicted anesthesia induction

    Procedure: Preoperative fasting instruction

  • Active comparator
    6H group

    Patients parents instructed to stop enteral feeding 6 hours before predicted anesthesia induction

    Procedure: Preoperative fasting instruction

Interventions

  • ProcedurePreoperative fasting instruction

    Patients parents instructed to stop enteral feeding at a specified time before predicted anesthesia induction

06

What researchers measure

Primary outcomes

  1. CSA

    Gastric antral surface area

    Time frame: Immediately before anesthesia induction

Secondary outcomes

  1. Suctioned GCV

    Gastric content volume suctioned through nasogastric tube after induction

    Time frame: Immediately after intubation

07

Study locations

1 of 1 sites recruiting
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05695066
Lead sponsor
Uppsala University Hospital
Responsible party
Peter Frykholm (Associate professor, Uppsala University Hospital) — Principal investigator
First posted
Jan 23, 2023
Start date
Jan 23, 2023
Primary completion
May 2025 (estimated)
Completion
Oct 2025 (estimated)
Last update
May 14, 2024

Study contacts

Peter Frykholm, MD, PhD
Contact
peter.frykholm@surgsci.uu.se
+46186171240
Ali-Reza Modiri, PhD
Contact
ali-reza.modiri@uu.se
+46727411410
Peter Frykholm, MD PhD
principal investigator · Uppsala University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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