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

NCT05695066 | Recruiting

• 1 other identifier: ENGUS
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Aspiration of Gastric Contents

Keywords

Preoperation fasting; Anaesthesia; Children; Enteral feeding

Outcome Measures

Primary Outcomes (1)

• CSA

  Gastric antral surface area

  Immediately before anesthesia induction

Secondary Outcomes (1)

• Suctioned GCV

  Immediately after intubation

Study Arms (2)

4H group

EXPERIMENTAL

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

Procedure: Preoperative fasting instruction

6H group

ACTIVE COMPARATOR

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

Procedure: Preoperative fasting instruction

Interventions

Preoperative fasting instruction PROCEDURE

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

4H group; 6H group

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uppsala University Hospital: lead

Study Sites (1)

Uppsala University Hospital

Uppsala, 75185, Sweden

RECRUITING

Related Links

• Pre-operative fasting in children: A guideline from the European Society of Anaesthesiology and Intensive Care
• Ultrasound assessment of gastric emptying time after a standardised light breakfast in healthy children: A prospective observational study.
• Gastric content assessed with gastric ultrasound in paediatric patients prescribed a light breakfast prior to general anaesthesia: A prospective observational study.

MeSH Terms

Conditions

Respiratory Aspiration of Gastric Contents

Condition Hierarchy (Ancestors)

Laryngopharyngeal Reflux; Gastroesophageal Reflux; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Respiratory Aspiration; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter Frykholm, MD PhD

  Uppsala University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Frykholm, MD, PhD

CONTACT

+46186171240; peter.frykholm@surgsci.uu.se

Ali-Reza Modiri, PhD

CONTACT

+46727411410; ali-reza.modiri@uu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Computerized randomization. Randomization outcome distributed via sealed envelopes. Randomization key stored on secure server.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Randomized controlled trial.

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: January 23, 2023
• Study Start: January 23, 2023
• Primary Completion: May 1, 2025
• Study Completion: October 1, 2025
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)