Examination of Gastric Emptying in Children

NCT ID: NCT01133691

Last Updated: 2012-01-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 31 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2011-02-28

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.

Conditions

Gastric Emptying

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

healthy children aged 6 - 12 years

clear fluid, light breakfast

Intervention Type: DIETARY_SUPPLEMENT

clear fluid 7 ml/kg, breakfast consisting of yoghurt, muesli, mild

Interventions

clear fluid, light breakfast

clear fluid 7 ml/kg, breakfast consisting of yoghurt, muesli, mild

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Children's Hospital, Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Achim J Schmitz, MD

Role: PRINCIPAL_INVESTIGATOR

Children's University Hospital Zurich, Anesthesiology

Locations

University Children's Hospital, Anesthesiology

Zurich, Canton of Zurich, Switzerland

Countries

Switzerland

Other Identifiers

KEK-ZH-Nr. 2009-0147

Identifier Type: -

Identifier Source: org_study_id