Examination of Gastric Emptying in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01133691
Recruitment Status : Completed
First Posted : May 31, 2010
Last Update Posted : January 18, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Gastric Emptying Dietary Supplement: clear fluid, light breakfast

Study Type : Observational
Actual Enrollment : 31 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Examination of Gastric Emptying With Magnetic Resonance Imaging and Ultrasonography
Study Start Date : May 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

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

Primary Outcome Measures :
  1. Gastric emptying time [ Time Frame: 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 :
  1. gastric volume after fasting [ Time Frame: 6 hours ]
  2. gastric antral area [ Time Frame: 6 hours ]
  3. visual analog scale of thirst/hunger [ Time Frame: 6 hours ]

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
healthy children aged 6 - 12 years old

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01133691

University Children's Hospital, Anesthesiology
Zurich, Switzerland, 8032
Sponsors and Collaborators
University Children's Hospital, Zurich
Principal Investigator: Achim J Schmitz, MD Children's University Hospital Zurich, Anesthesiology

Responsible Party: University Children's Hospital, Zurich Identifier: NCT01133691     History of Changes
Other Study ID Numbers: KEK-ZH-Nr. 2009-0147
First Posted: May 31, 2010    Key Record Dates
Last Update Posted: January 18, 2012
Last Verified: January 2012

Keywords provided by University Children's Hospital, Zurich:
gastric emptying
gastric fluid volume
preoperative fasting