Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05695066
Other study ID # ENGUS
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 23, 2023
Est. completion date October 2025

Study information

Verified date May 2024
Source Uppsala University Hospital
Contact Peter Frykholm, MD, PhD
Phone +46186171240
Email peter.frykholm@surgsci.uu.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 180
Est. completion date October 2025
Est. primary completion date May 2025
Accepts healthy volunteers No
Gender All
Age group 6 Months to 12 Years
Eligibility Inclusion Criteria: Child on intermittent or continuous enteral nutrition, scheduled for elective procedure requiring general anesthesia 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

Study Design


Related Conditions & MeSH terms

  • Pulmonary Aspiration of Gastric Contents
  • Respiratory Aspiration of Gastric Contents

Intervention

Procedure:
Preoperative fasting instruction
Patients parents instructed to stop enteral feeding at a specified time before predicted anesthesia induction

Locations

Country Name City State
Sweden Uppsala University Hospital Uppsala

Sponsors (1)

Lead Sponsor Collaborator
Uppsala University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary CSA Gastric antral surface area Immediately before anesthesia induction
Secondary Suctioned GCV Gastric content volume suctioned through nasogastric tube after induction Immediately after intubation
See also
  Status Clinical Trial Phase
Completed NCT04097236 - Body Position and Ultrasound Examination of the Gastric Antrum N/A
Completed NCT02749175 - SMART Study (Sellick's Maneuver Assisted Real Time) to Deliver Target Cricoid Pressure in Simulated Environment N/A
Completed NCT01798342 - Safety of Gastric Volume Emptying After the Intake of Maltodextrin and Glutamine Phase 2
Completed NCT05922072 - Comparison of Different Preoperative Fasting Times in Pediatric Patients Undergoing Elective General Anaesthesia N/A
Not yet recruiting NCT06388213 - Investigation of the Evolution of Gastric Emptying by Gastric Ultra Sonography in Patients Treated With GLP-1 Receptor Agonists on a 7 Days Pausing Period.
Completed NCT04794764 - Videolaryngoscopy Compared to Direct Laryngoscopy N/A
Completed NCT02703896 - Prophylaxis for Aspiration of Gastric Contents. Phase 4
Recruiting NCT05519969 - A Multicentre Preoperative Fasting Audit