Back to resultsUltrasound Assessment of Gastric Content for Semi Emergency Surgery (ECHO-GAST)
Primary Purpose
Anesthesia, Surgical Procedure, Unspecified
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ultrasonography
Sponsored by
About this trial
This is an interventional diagnostic trial for Anesthesia focused on measuring Ultrasonography, Non-elective surgery, Anesthesia
Eligibility Criteria
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.
Sites / Locations
- Chu de Saint Etienne
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SEMI EMERGENCY SURGERY PATIENT
Arm Description
patient undergoing a non-elective surgery and having a preoperative fasting period of six hours.
Outcomes
Primary Outcome Measures
patients with full stomach
Full stomach is defined by an antral cross-section area (CSA) > 410 mm2, measured by ultrasonography
Secondary Outcome Measures
duration of preoperative fasting
type of surgery disease
preoperative pain
Visual Analog Scale
feeling of hunger
nausea and vomiting
number of patients with nausea and vomiting
type of anesthetic procedure performed
rapid or standard anesthetic induction
inhalation of gastric contents
number of patients with inhalation of gastric contents during intervention
Full Information
NCT ID
NCT02386787
First Posted
February 20, 2015
Last Updated
May 24, 2016
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
1. Study Identification
Unique Protocol Identification Number
NCT02386787
Brief Title
Ultrasound Assessment of Gastric Content for Semi Emergency Surgery
Acronym
ECHO-GAST
Official Title
Ultrasound Assessment of Gastric Content for Semi Emergency Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Surgical Procedure, Unspecified
Keywords
Ultrasonography, Non-elective surgery, Anesthesia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SEMI EMERGENCY SURGERY PATIENT
Arm Type
Experimental
Arm Description
patient undergoing a non-elective surgery and having a preoperative fasting period of six hours.
Intervention Type
Device
Intervention Name(s)
Ultrasonography
Intervention Description
an ultrasonography will be conducted before the anesthesic procedure to provide reliable quantitative information about the volume of gastric content.
Primary Outcome Measure Information:
Title
patients with full stomach
Description
Full stomach is defined by an antral cross-section area (CSA) > 410 mm2, measured by ultrasonography
Time Frame
baseline
Secondary Outcome Measure Information:
Title
duration of preoperative fasting
Time Frame
baseline
Title
type of surgery disease
Time Frame
baseline
Title
preoperative pain
Description
Visual Analog Scale
Time Frame
baseline
Title
feeling of hunger
Time Frame
baseline
Title
nausea and vomiting
Description
number of patients with nausea and vomiting
Time Frame
baseline
Title
type of anesthetic procedure performed
Description
rapid or standard anesthetic induction
Time Frame
baseline
Title
inhalation of gastric contents
Description
number of patients with inhalation of gastric contents during intervention
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie GAVORY, MD
Organizational Affiliation
CHU de Saint Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu de Saint Etienne
City
Saint Etienne
ZIP/Postal Code
42055
Country
France
12. IPD Sharing Statement
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Ultrasound Assessment of Gastric Content for Semi Emergency Surgery
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