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CompletedNCT02386787ECHO-GASTUpdated May 25, 2016

Ultrasound Assessment of Gastric Content for Semi Emergency Surgery

An interventional study of Ultrasonography in Anesthesia and Surgical Procedure, Unspecified, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-25.

Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Anesthesia
  • Surgical Procedure, Unspecified

Keywords

  • Ultrasonography
  • Non-elective surgery
  • Anesthesia
03

In context

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 597 studies on the registry; 127 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
300 participants (actual)

Study arms

  • Experimental
    SEMI EMERGENCY SURGERY PATIENT

    patient undergoing a non-elective surgery and having a preoperative fasting period of six hours.

    Device: Ultrasonography

Interventions

  • DeviceUltrasonography

    an ultrasonography will be conducted before the anesthesic procedure to provide reliable quantitative information about the volume of gastric content.

06

What researchers measure

Primary outcomes

  1. patients with full stomach

    Full stomach is defined by an antral cross-section area (CSA) \> 410 mm2, measured by ultrasonography

    Time frame: baseline

Secondary outcomes

  1. duration of preoperative fasting

    Time frame: baseline

  2. type of surgery disease

    Time frame: baseline

  3. preoperative pain

    Visual Analog Scale

    Time frame: baseline

  4. feeling of hunger

    Time frame: baseline

  5. nausea and vomiting

    number of patients with nausea and vomiting

    Time frame: baseline

  6. type of anesthetic procedure performed

    rapid or standard anesthetic induction

    Time frame: baseline

  7. inhalation of gastric contents

    number of patients with inhalation of gastric contents during intervention

    Time frame: baseline

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Study locations

1 site
  • Chu de Saint Etienne
    Saint-Etienne, 42055, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02386787
Responsible party
Sponsor
First posted
Mar 12, 2015
Start date
May 2014
Primary completion
Mar 2016
Completion
Apr 2016
Last update
May 25, 2016

Study contacts

Julie GAVORY, MD
principal investigator · CHU de Saint Etienne

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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