NCT02936882

Brief Summary

This study evaluates antral ultrasonography for the diagnosis of full stomach before surgical emergencies in pediatric population. Preoperative ultrasonographic antral evaluation is compared to peroperative gastric aspirate with nasogastric tube.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Last Updated

October 18, 2016

Status Verified

October 1, 2016

Enrollment Period

9 months

First QC Date

October 6, 2016

Last Update Submit

October 14, 2016

Conditions

Gastric ContentFull Stomach Status

Keywords

ultrasonographyaspirationemergencychildrenantrum

Outcome Measures

Primary Outcomes (1)

  • Volume of gastric content aspirated throw nasogastric tube

    20 min

Secondary Outcomes (7)

  • Grades as described by Perlas et al. for ultrasonographic qualitative evaluation of gastric content

    20 min

  • relationship between peroperative gastric content and ultrasonographic antrum assessment

    20 min

  • Time to perform antral ultrasonography

    20 min

  • Quality of image obtained during antral ultrasonography

    20 min

  • Child behaviour during antral ultrasonography

    20 min

  • +2 more secondary outcomes

Study Arms (1)

Preoperative gastric ultrasonography

OTHER
Procedure: Preoperative gastric ultrasonography

Interventions

Preoperative gastric ultrasonographyPROCEDURE

Before surgical emergency procedure, a preoperative antral ultrasonography is performed to assess gastric content.

Preoperative gastric ultrasonography

Eligibility Criteria

Age3 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Surgical emergency procedure
  • ASA I-II

You may not qualify if:

  • Ultrasound antrum assessment not possible
  • No nasogastric tube during surgery
  • Vital emergency
  • Patient from Critical Care Ward
  • Time between ultrasound assessment and gastric content collecting up to 20min
  • Child and/or Parents doesn't/don't want to participate in the study
  • Personal medical history of gastric or oesophagus desease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necker Enfants-Malades University Hospital - APHP

Paris, 75015, France

RECRUITING

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

October 6, 2016

First Posted

October 18, 2016

Study Start

March 1, 2016

Primary Completion

December 1, 2016

Last Updated

October 18, 2016

Record last verified: 2016-10

Locations

FR(1)