AnesthesiaECHO-GASTNCT02386787
Ultrasound Assessment of Gastric Content for Semi Emergency Surgery
A study testing Ultrasonography in people with Anesthesia and Surgical Procedure, Unspecified, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Surgical Procedure, Unspecified
- What is being tested?
- Ultrasonography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- May 2014to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- undergoing a non-elective surgery
- having a preoperative fasting period of six hours
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Anesthesia, Surgical Procedure, Unspecified
- Being tested
- Ultrasonography
- Keywords
- Ultrasonography, Non-elective surgery, Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasonographyDevice
an ultrasonography will be conducted before the anesthesic procedure to provide reliable quantitative information about the volume of gastric content.
| Study group | Role | What they receive |
|---|---|---|
| SEMI EMERGENCY SURGERY PATIENT | Experimental | patient undergoing a non-elective surgery and having a preoperative fasting period of six hours. Receives: Device: Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
patients with full stomach
Full stomach is defined by an antral cross-section area (CSA) > 410 mm2, measured by ultrasonography
Measured: baseline
Secondary outcomes (7)
duration of preoperative fasting
Measured: baseline
type of surgery disease
Measured: baseline
preoperative pain
Visual Analog Scale
Measured: baseline
feeling of hunger
Measured: baseline
nausea and vomiting
number of patients with nausea and vomiting
Measured: baseline
type of anesthetic procedure performed
rapid or standard anesthetic induction
Measured: baseline
inhalation of gastric contents
number of patients with inhalation of gastric contents during intervention
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2015 (estimated)
- Study startMay 2014
- Primary completionMar 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie GAVORY, MD, Principal investigator, CHU de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02386787
- Sponsor's protocol ID
- 1308170
- Other IDs
- 2013-A01649-36
- Acronym
- ECHO-GAST
- Status last verified
- Mar 2016
- First submitted
- 20 Feb 2015
- Last updated
- 25 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Assessment of Gastric Content for Semi Emergency Surgery
- ClinicalTrials.gov ID
- NCT02386787
- Acronym / sponsor ID
- ECHO-GAST / 1308170
- Conditions
- Anesthesia, Surgical Procedure, Unspecified
- Keywords
- Ultrasonography, Non-elective surgery, Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 12 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SEMI EMERGENCY SURGERY PATIENT | Experimental | Device: Ultrasonographypatient undergoing a non-elective surgery and having a preoperative fasting period of six hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- undergoing a non-elective surgery
- having a preoperative fasting period of six hours
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasonographyan ultrasonography will be conducted before the anesthesic procedure to provide reliable quantitative information about the volume of gastric content. | Device | SEMI EMERGENCY SURGERY PATIENT |
Primary outcome
patients with full stomach
Time frame: baseline
Full stomach is defined by an antral cross-section area (CSA) > 410 mm2, measured by ultrasonography
7 secondary outcomes
duration of preoperative fasting
Time frame: baseline
type of surgery disease
Time frame: baseline
preoperative pain
Time frame: baseline
feeling of hunger
Time frame: baseline
nausea and vomiting
Time frame: baseline
type of anesthetic procedure performed
Time frame: baseline
inhalation of gastric contents
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie GAVORY, MD principal investigator
CHU de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonography in people with Anesthesia and Surgical Procedure, Unspecified, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patients with full stomach (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2016; AzTrials last refreshed its copy on 8 Nov 2026.