Ultrasound Assessment of Gastric Content for Semi Emergency Surgery (ECHO-GAST)

May 24, 2016 updated by: Centre Hospitalier Universitaire de Saint Etienne
Aspiration of gastric content is a rare but serious complication of anesthesia. In this context, preoperative fasting for elective surgery is well defined. In an emergency situation, international guidelines recommend rapid sequence of anesthesia to reduce the risk of aspiration. In semi emergency situation, there is no consensus about the anesthetic procedure even if a preoperative fasting has been observed due to uncertainty of gastric emptying related to stress or painful condition. The choice of anesthesia induction technique depends mainly on the anesthetist. Ultrasonography is a non invasive bedside tool that can provide reliable quantitative information about the volume of gastric content.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

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
      • Saint Etienne, France, 42055
        • CHU de Saint Etienne

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • undergoing a non-elective surgery
  • having a preoperative fasting period of six hours

Exclusion Criteria:

  • patients with digestive diseases (gastroesophageal reflux disease, hiatal hernia, active peptic ulcer, upper gastrointestinal bleeding, vagal denervation, pyloric stenosis, extrinsic digestive compression, occlusive syndrome), neurologic diseases (spinal cord injury over T10, amylose, Shy-Drager syndrome)
  • patients with full stomach (preoperative fasting under 6 hours),
  • pregnant women (over 15 weeks of amenorrhea)
  • patients who received premedication.

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
Experimental: SEMI EMERGENCY SURGERY PATIENT
patient undergoing a non-elective surgery and having a preoperative fasting period of six hours.
Device: Ultrasonography
an ultrasonography will be conducted before the anesthesic procedure to provide reliable quantitative information about the volume of gastric content.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patients with full stomach
Time Frame: baseline
Full stomach is defined by an antral cross-section area (CSA) > 410 mm2, measured by ultrasonography
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration of preoperative fasting
Time Frame: baseline
baseline
type of surgery disease
Time Frame: baseline
baseline
preoperative pain
Time Frame: baseline
Visual Analog Scale
baseline
feeling of hunger
Time Frame: baseline
baseline
nausea and vomiting
Time Frame: baseline
number of patients with nausea and vomiting
baseline
type of anesthetic procedure performed
Time Frame: baseline
rapid or standard anesthetic induction
baseline
inhalation of gastric contents
Time Frame: baseline
number of patients with inhalation of gastric contents during intervention
baseline

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Julie GAVORY, MD, CHU de Saint Etienne

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

May 1, 2014

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

February 20, 2015

First Submitted That Met QC Criteria

March 11, 2015

First Posted (Estimate)

March 12, 2015

Study Record Updates

Last Update Posted (Estimate)

May 25, 2016

Last Update Submitted That Met QC Criteria

May 24, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1308170
  • 2013-A01649-36 (Other Identifier: ANSM)

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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