Examination of Gastric Emptying in Children

Examination of Gastric Emptying With Magnetic Resonance Imaging and Ultrasonography

• Background: Fasting is mandatory for safety of anesthesia in elective surgery and imaging but gives rise to discomfort, hunger and thirst especially in children. Internationally accepted fasting times are often prolonged because of organisational delay in operating theatre.
• Hypothesis: Clear fluids can be ingested until an imaginary anesthesia induction time without enlarging the residual gastric contents compared to overnight fast. There is no difference between residual gastric contents after 4 hours of fasting after a light meal compare to 6 hours in healthy children.
• Examination of gastric volume using magnetic resonance imaging after overnight fasting and subsequent scans after either clear fluid intake or intake of a standard breakfast are performed in children aged 6 - 12 years. Time course after fluid intake is followed with scans every half hour for 2 hours. In the breakfast group 4 versus 6 hours fasting time will be simulated, e. g. intake of clear fluid is allowed for 2 versus 4 hours after the meal. Volume of gastric contents will be compared with a standardized ultrasonographic view of the stomach.

Study Overview

• Status: Completed
• Conditions: Gastric Emptying
• Intervention / Treatment: Dietary supplement: clear fluid, light breakfast

• Study Type: Observational
• Enrollment (Actual): 31

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8032
    • University Children's Hospital, Anesthesiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

healthy children aged 6 - 12 years old

Description

Inclusion Criteria:

• age 6 - 12 years
• ASA I or II

Exclusion Criteria:

• gastrointestinal pathology
• claustrophobia
• implants like pacemaker, ventriculoperitoneal shunt etc
• symptomatic or relevant cardiac, renal or metabolic disease

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
healthy children aged 6 - 12 years	Dietary supplement: clear fluid, light breakfast; clear fluid 7 ml/kg, breakfast consisting of yoghurt, muesli, mild

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastric emptying time	Time after food/fluid ingestion when gastric volume after overnight fast is achieved, as measured by volumetry of magnetic resonance scans	6 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
gastric volume after fasting	6 hours
gastric antral area	6 hours
visual analog scale of thirst/hunger	6 hours

Collaborators and Investigators

• Sponsor: University Children's Hospital, Zurich
• Investigators: Principal Investigator: Achim J Schmitz, MD, Children's University Hospital Zurich, Anesthesiology

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: May 11, 2010
• First Submitted That Met QC Criteria: May 28, 2010
• First Posted (Estimate): May 31, 2010

Study Record Updates

• Last Update Posted (Estimate): January 18, 2012
• Last Update Submitted That Met QC Criteria: January 16, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: children; gastric emptying; gastric fluid volume; preoperative fasting
• Other Study ID Numbers: KEK-ZH-Nr. 2009-0147

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No