Ultrasound Assessment of Gastric Content Before Anesthesia for Appendectomy (EGASTA)

December 5, 2016 updated by: Central Hospital, Nancy, France

Ultrasound Assessment of Gastric Content and Gastric Volume Before Crash Induction for Appendectomy

Performing anesthetic induction for appendicectomy has two main risks : first aspiraion of gastric content causing pneumonia. Otherwise, anaphylactic risk to drugs used during anesthetic induction. Indeed, the guidelines recommend an anesthetic induction protocol qualified "full stomach" whatever the patient and the preoperative fasting period are. This protocol provides the use of fast-acting neuromuscular blocking agents (succinylcholine or rocuronium). However, these neuromuscular blocking agents are ten times more at allergic risk than others. Ultrasound assessment of gastric content before rapid sequence induction of anesthesia is a reproducible, non-invasive, inexpensive and quickly achievable bedside technique. Furthermore, the correlations between gastric volume and risk of a full stomach and also between the cross-section antral area (CSA) and the risk of a full stomach have been validated on several patient cohorts. We formulate the hypothesis that the achievement of a gastric ultrasound before anesthetic induction for appendectomy could allow to identify "full stomach" patients who actually justify rapid sequence induction of anesthesia with exposure to fast-acting neuromuscular blocking agents that implies.

Primary endpoint is to determine te percentage of patients who have a gastric content before appendectomy. Secondary endpoint is to determine the incidenc of aspiration pneumonia and anaphylactic shock. Another secondary endpoint is to determine the percentage of patient with gastric content with the antral grading system (Perlas method) and to evaluate the concordance between this methode and the cross-section antral area.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

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.

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

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient admitted to the operating room for appendectomy.
  • Major or minor patient (higher than 16) affiliated to a social security scheme.
  • Patient or parents of minor patient who received the full information relative to the organization of the study and who signed his/their informed consent(s).

Exclusion Criteria:

  • Pregnant women.
  • Childbearing age patient does not have effective contraception.
  • Breastfeeding woman.
  • Minor patient under 16.
  • Major patient subject to a measure of legal protection or unable to consent.
  • Persons deprived of liberty by a judicial or an administrative decision.
  • Patient with gastric and/or esophagus surgery history.

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ultrasound assessment of gastric content
Other: ultrasound assessment of gastric content

Achievement of gastric ultrasound (specific procedure) :

Gastric ultrasound is performed specifically for the study by a senior anesthetist physician in a patient placed supine, semi-sitting by an angle of 45 ° relative to the horizontal.

Standardised achievement of the antral ultrasound by the following method:

  • First, a qualitative assessment of antral contents in 3 grades according to the "Perlas" method [24].
  • Second, performing a quantitative analysis of antral contents calculating the CSA.
  • Then, volume of gastric contents calculation as from the CSA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cross-section antral area (CSA)
Time Frame: baseline J0
Ultrasonography exam of the stomach is used to evaluate the CSA. A CSA greater than 340mm² defines a full stomach. The calculation of the CSA is : CSA = AP x CC x π / 4 (in mm²). With AP - antero-posterior gastric antrum diameter and CC - cranio-caudal gastric antrum diameter
baseline J0

Collaborators and Investigators

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

Sponsor

Central Hospital, Nancy, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2016

Primary Completion (Anticipated)

August 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

December 2, 2016

First Submitted That Met QC Criteria

December 5, 2016

First Posted (Estimate)

December 6, 2016

Study Record Updates

Last Update Posted (Estimate)

December 6, 2016

Last Update Submitted That Met QC Criteria

December 5, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2016-A01501-50

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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