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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

May 11, 2010
January 16, 2012
May 2010
February 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01133691 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Examination of Gastric Emptying in Children
Examination of Gastric Emptying With Magnetic Resonance Imaging and Ultrasonography
  • 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.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

healthy children aged 6 - 12 years old

Gastric Emptying
Dietary Supplement: clear fluid, light breakfast
clear fluid 7 ml/kg, breakfast consisting of yoghurt, muesli, mild
healthy children aged 6 - 12 years
Intervention: Dietary Supplement: clear fluid, light breakfast
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
February 2011
February 2011   (final data collection date for primary outcome measure)

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
Both
6 Years to 12 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01133691
KEK-ZH-Nr. 2009-0147
No
University Children's Hospital, Zurich
University Children's Hospital, Zurich
Not Provided
Principal Investigator: Achim J Schmitz, MD Children's University Hospital Zurich, Anesthesiology
University Children's Hospital, Zurich
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP