Evaluation of Antral Ultrasonography for Full Stomach Diagnosis Before Pediatric Surgical Emergencies

October 14, 2016 updated by: Olivier MAUPAIN, Hôpital Necker-Enfants Malades
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • Recruiting
        • Necker Enfants-Malades University Hospital - APHP
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Surgical emergency procedure
  • ASA I-II

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Preoperative gastric ultrasonography
Procedure: Preoperative gastric ultrasonography
Before surgical emergency procedure, a preoperative antral ultrasonography is performed to assess gastric content.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Volume of gastric content aspirated throw nasogastric tube
Time Frame: 20 min
20 min

Secondary Outcome Measures

Outcome Measure
Time Frame
Grades as described by Perlas et al. for ultrasonographic qualitative evaluation of gastric content
Time Frame: 20 min
20 min
relationship between peroperative gastric content and ultrasonographic antrum assessment
Time Frame: 20 min
20 min
Time to perform antral ultrasonography
Time Frame: 20 min
20 min
Quality of image obtained during antral ultrasonography
Time Frame: 20 min
20 min
Child behaviour during antral ultrasonography
Time Frame: 20 min
20 min
Number of participants with exploitable antral ultrasonography
Time Frame: 20 min
20 min
Reasons for antral ultrasonography failure
Time Frame: 20 min
20 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hôpital Necker-Enfants Malades

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

October 6, 2016

First Submitted That Met QC Criteria

October 14, 2016

First Posted (Estimate)

October 18, 2016

Study Record Updates

Last Update Posted (Estimate)

October 18, 2016

Last Update Submitted That Met QC Criteria

October 14, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DAR_NCK_OMN0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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