Examination of Gastric Emptying in Children

NCT01133691 | Completed

• 1 other identifier: KEK-ZH-Nr. 2009-0147
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

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

Keywords

gastric emptying; children; gastric fluid volume; preoperative fasting

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• gastric volume after fasting

  6 hours

• gastric antral area

  6 hours

• visual analog scale of thirst/hunger

  6 hours

Study Arms (1)

healthy children aged 6 - 12 years

Dietary Supplement: clear fluid, light breakfast

Interventions

clear fluid, light breakfast DIETARY_SUPPLEMENT

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

healthy children aged 6 - 12 years

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

healthy children aged 6 - 12 years old

You may qualify if:

• age 6 - 12 years
• ASA I or II

You may not qualify if:

• gastrointestinal pathology
• claustrophobia
• implants like pacemaker, ventriculoperitoneal shunt etc
• symptomatic or relevant cardiac, renal or metabolic disease

Sponsors & Collaborators

• University Children's Hospital, Zurich: lead

Study Sites (1)

University Children's Hospital, Anesthesiology

Zurich, Canton of Zurich, 8032, Switzerland

Location

Study Officials

• Achim J Schmitz, MD

  Children's University Hospital Zurich, Anesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2010
• First Posted: May 31, 2010
• Study Start: May 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: January 18, 2012

Record last verified: 2012-01

Locations

CH (1)