Examination of Gastric Emptying in Children

Gastric Emptying Clinical Trial

Official title:

Examination of Gastric Emptying With Magnetic Resonance Imaging and Ultrasonography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01133691
• Other study ID #: KEK-ZH-Nr. 2009-0147
• Status: Completed
• Phase: N/A
• First received: May 11, 2010
• Last updated: January 16, 2012
• Start date: May 2010
• Est. completion date: February 2011

Study information

• Verified date: January 2012
• Source: University Children's Hospital, Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastric Emptying

Intervention

Dietary Supplement:
• clear fluid, light breakfast
clear fluid 7 ml/kg, breakfast consisting of yoghurt, muesli, mild

Locations

Country	Name	City	State
Switzerland	University Children's Hospital, Anesthesiology	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University Children's Hospital, Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	gastric volume after fasting		6 hours	No
Secondary	gastric antral area		6 hours	No
Secondary	visual analog scale of thirst/hunger		6 hours	No