Examination of Gastric Emptying in Children

Completed

• Conditions: Gastric Emptying
• Interventions: Dietary Supplement: clear fluid, light breakfast

• Registration Number: NCT01133691
• Lead Sponsor: University Children's Hospital, Zurich

Brief Summary

* 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-11
• Study First Submitted QC: 2010-05-28
• Study First Posted: 2010-05-31
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-16
• Last Update Posted: 2012-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
healthy children aged 6 - 12 years	clear fluid, light breakfast	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
gastric volume after fasting	6 hours
visual analog scale of thirst/hunger	6 hours
gastric antral area	6 hours

Trial Locations

Locations (1)

University Children's Hospital, Anesthesiology; 🇨🇭 Zurich, Switzerland