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Examination of Gastric Emptying in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Children's Hospital, Zurich
ClinicalTrials.gov Identifier:
NCT01133691
First received: May 11, 2010
Last updated: January 16, 2012
Last verified: January 2012
History of Changes
  Purpose
  • 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 Intervention
Gastric Emptying
 Dietary Supplement: clear fluid, light breakfast

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Examination of Gastric Emptying With Magnetic Resonance Imaging and Ultrasonography

Resource links provided by NLM:

MedlinePlus related topics: MRI Scans
U.S. FDA Resources

Further study details as provided by University Children's Hospital, Zurich:

Primary Outcome Measures:
  • Gastric emptying time [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    Time after food/fluid ingestion when gastric volume after overnight fast is achieved, as measured by volumetry of magnetic resonance scans


Secondary Outcome Measures:
  • gastric volume after fasting [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  • gastric antral area [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  • visual analog scale of thirst/hunger [ Time Frame: 6 hours ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: May 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
healthy children aged 6 - 12 years Dietary Supplement: clear fluid, light breakfast
clear fluid 7 ml/kg, breakfast consisting of yoghurt, muesli, mild

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

healthy children aged 6 - 12 years old

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01133691

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

No publications provided

Responsible Party: University Children's Hospital, Zurich
ClinicalTrials.gov Identifier: NCT01133691     History of Changes
Other Study ID Numbers: KEK-ZH-Nr. 2009-0147
Study First Received: May 11, 2010
Last Updated: January 16, 2012
Health Authority: Switzerland: Swissmedic

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

ClinicalTrials.gov processed this record on May 22, 2013