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

Primary Purpose

Pulmonary Aspiration of Gastric Contents

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Preoperative fasting instruction
Sponsored by
Uppsala University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pulmonary Aspiration of Gastric Contents focused on measuring Preoperation fasting, Anaesthesia, Children, Enteral feeding

Eligibility Criteria

6 Months - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Uppsala University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

4H group

6H group

Arm Description

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

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

Outcomes

Primary Outcome Measures

CSA
Gastric antral surface area

Secondary Outcome Measures

Suctioned GCV
Gastric content volume suctioned through nasogastric tube after induction

Full Information

First Posted
January 12, 2023
Last Updated
January 22, 2023
Sponsor
Uppsala University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05695066
Brief Title
Gastric Content After 6 vs 4 Hours of Preoperative Fasting in Children
Acronym
ENGUS
Official Title
Gastric Content After 6 vs 4 Hours of Preoperative Fasting in Children on Enteral Nutrition. A Randomized Controlled Trial Using Gastric Ultrasound
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 23, 2023 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
October 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uppsala University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Aspiration of Gastric Contents
Keywords
Preoperation fasting, Anaesthesia, Children, Enteral feeding

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial.
Masking
InvestigatorOutcomes Assessor
Masking Description
Computerized randomization. Randomization outcome distributed via sealed envelopes. Randomization key stored on secure server.
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
4H group
Arm Type
Experimental
Arm Description
Patients parents instructed to stop enteral feeding 4 hours before predicted anesthesia induction
Arm Title
6H group
Arm Type
Active Comparator
Arm Description
Patients parents instructed to stop enteral feeding 6 hours before predicted anesthesia induction
Intervention Type
Procedure
Intervention Name(s)
Preoperative fasting instruction
Intervention Description
Patients parents instructed to stop enteral feeding at a specified time before predicted anesthesia induction
Primary Outcome Measure Information:
Title
CSA
Description
Gastric antral surface area
Time Frame
Immediately before anesthesia induction
Secondary Outcome Measure Information:
Title
Suctioned GCV
Description
Gastric content volume suctioned through nasogastric tube after induction
Time Frame
Immediately after intubation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Frykholm, MD, PhD
Phone
+46186171240
Email
peter.frykholm@surgsci.uu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Ali-Reza Modiri, PhD
Phone
+46727411410
Email
ali-reza.modiri@uu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Frykholm, MD PhD
Organizational Affiliation
Uppsala University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uppsala University Hospital
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Frykholm, MD PhD
Phone
+46708454969
Email
peter.frykholm@surgsci.uu.se
First Name & Middle Initial & Last Name & Degree
Ali Modiri, PhD
Phone
+467411410
Email
alireza.modiri@akademiska.se

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/34857683/
Description
Pre-operative fasting in children: A guideline from the European Society of Anaesthesiology and Intensive Care
URL
https://pubmed.ncbi.nlm.nih.gov/30095551/
Description
Ultrasound assessment of gastric emptying time after a standardised light breakfast in healthy children: A prospective observational study.
URL
https://pubmed.ncbi.nlm.nih.gov/31608517/
Description
Gastric content assessed with gastric ultrasound in paediatric patients prescribed a light breakfast prior to general anaesthesia: A prospective observational study.

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

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