Examination of Gastric Emptying in Children | NCT01133691

Studies
Examination of Gastric Emptying in Children

NCT01133691

Sponsor

University Children's Hospital, Zurich

Status

Completed

Last Update Posted

Jan 18, 2012Estimated

Enrollment

31Actual

Phase

Not provided

Conditions

Gastric Emptying

Interventions

clear fluid, light breakfast

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Feb 2011Actual

Completion Date

Feb 2011Actual

First Submitted Date

May 11, 2010

First Submission Date that Met QC Criteria

May 28, 2010

First Posted Date

May 31, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 16, 2012

Last Update Posted Date

Jan 18, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
healthy children aged 6 - 12 years			Dietary Supplement: clear fluid, light breakfast

Interventions

Name	Type	Description	Arm Group Labels	Other Names
clear fluid, light breakfast	Dietary Supplement	clear fluid 7 ml/kg, breakfast consisting of yoghurt, muesli, mild	healthy children aged 6 - 12 years

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
gastric volume after fasting		6 hours
gastric antral area		6 hours
visual analog scale of thirst/hunger

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

healthy children aged 6 - 12 years old

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Achim J Schmitz, MD	Children's University Hospital Zurich, Anesthesiology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Children's Hospital, Anesthesiology		Zurich	Canton of Zurich	8032	Switzerland