Echocardiography, Three-DimensionalECHO3DGASTRIQNCT02819466
Visualization of the Stomach During Fasting and Measurement of Intragastric Volume After Ingestion of Fluid: Feasibility and Application of Three Dimensional Ultrasound in Healthy Subjects
An observational study of Echocardiography, Three-Dimensional, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Aspiration pneumonia is a dreaded complication of anaesthesia because of its prevalence (1/3,886 cases in elective anaesthesia and 1/895 cases in emergency settings) and its high morbidity and mortality (3 to 9%). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Echocardiography, Three-Dimensional
- What is being tested?
- 3D echography
- Type of treatment
- Medical device
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2013to Jun 2015
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers fasting
Who may be able to join
- Healthy volunteers over the age of 18 years employed by Amiens University Hospital and covered by French national health insurance.
- Fasting (last meal > 6 hours and last drink of water, tea or coffee > 2 hours)
- Signature of the free and informed written consent form.
Who cannot join
- Pregnant woman.
- Presence of diseases or treatments that alter (slow or accelerate) gastric emptying.
- Presence of swallowing disorders.
- History of gastric or supramesocolic surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Visualization of the Stomach During Fasting and Measurement of Intragastric Volume After Ingestion of Fluid: Feasibility and Application of Three Dimensional Ultrasound in Healthy Subjects. ECHO3DGASTRIQUE Study
Aspiration pneumonia is a dreaded complication of anaesthesia because of its prevalence (1/3,886 cases in elective anaesthesia and 1/895 cases in emergency settings) and its high morbidity and mortality (3 to 9%). This chemical and/or infectious pneumonia is secondary to passage of the gastric contents into the unprotected upper airways during general anaesthesia. The prognosis depends on three factors: the presence of food debris, and the acidity and volume of the gastric contents. To prevent this complication, the French society of anaesthesia and intensive care recommends preoperative fasting rules and, in patients presenting risk factors for aspiration, the use of antacids and rapid sequence intubation. This preventive strategy is associated with certain adverse events: deferred operative procedures, discomfort and hypoglycaemia secondary to fasting, more frequent anaphylactic complications, and memory of anaesthetic induction.
Over recent years, ultrasound has become more widely used by anaesthetists for local anaesthesia, vascular catheterization, haemodynamic monitoring and, more recently, 2D ultrasound estimation of intragastric volume. However, 2D ultrasound estimation of intragastric volume presents several limitations: because of the complex shape of the stomach, this technique requires a long learning curve and the measured volume is poorly correlated with reference techniques (MRI and 99Tc scintigraphy). Two studies have recently measured intragastric volume by three dimensional ultrasound with promising results.
- Conditions
- Echocardiography, Three-Dimensional
- Being tested
- 3D echography
- Keywords
- intragastric volume, stomach, fasting
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D echographyDevice
ultrasound visualization of the stomach in fasting patients.
| Study group | Role | What they receive |
|---|---|---|
| volunteers | Healthy volunteers over the age of 18 years employed by Amiens University Hospital 3D echography Receives: Device: 3D echography |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate of ultrasound visualization of the stomach while fasting
success rate of ultrasound visualization of the stomach while fasting
Measured: Day 0
Secondary outcomes (4)
ultrasound visualization of the fasting stomach learning curve
ultrasound visualization of the fasting stomach learning curve for each investigator
Measured: Day 0
measured difference of antral surface area
antral surface area after ingestion of fluid - fasting antral surface area
Measured: Day 0
absolute error of the volume measured
ingested volume - intragastric volume variation
Measured: Day 0
relative error of the volume measured
(absolute error / ingested volume) * 100
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study startApr 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Echocardiography, Three-DimensionalStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edouard SECQ, PhD, Principal investigator, CHU AmiensEmmanuel LORNE, MD, PhD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02819466
- Sponsor's protocol ID
- PI2012_843_0027
- Acronym
- ECHO3DGASTRIQ
- Status last verified
- Jun 2016
- First submitted
- 28 Jun 2016
- Last updated
- 30 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visualization of the Stomach During Fasting and Measurement of Intragastric Volume After Ingestion of Fluid: Feasibility and Application of Three Dimensional Ultrasound in Healthy Subjects. ECHO3DGASTRIQUE Study
- ClinicalTrials.gov ID
- NCT02819466
- Acronym / sponsor ID
- ECHO3DGASTRIQ / PI2012_843_0027
- Conditions
- Echocardiography, Three-Dimensional
- Keywords
- intragastric volume, stomach, fasting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 30 Jun 2016 (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 pneumonia is a dreaded complication of anaesthesia because of its prevalence (1/3,886 cases in elective anaesthesia and 1/895 cases in emergency settings) and its high morbidity and mortality (3 to 9%). This chemical and/or infectious pneumonia is secondary to passage of the gastric contents into the unprotected upper airways during general anaesthesia. The prognosis depends on three factors: the presence of food debris, and the acidity and volume of the gastric contents. To prevent this complication, the French society of anaesthesia and intensive care recommends preoperative fasting rules and, in patients presenting risk factors for aspiration, the use of antacids and rapid sequence intubation. This preventive strategy is associated with certain adverse events: deferred operative procedures, discomfort and hypoglycaemia secondary to fasting, more frequent anaphylactic complications, and memory of anaesthetic induction.
Over recent years, ultrasound has become more widely used by anaesthetists for local anaesthesia, vascular catheterization, haemodynamic monitoring and, more recently, 2D ultrasound estimation of intragastric volume. However, 2D ultrasound estimation of intragastric volume presents several limitations: because of the complex shape of the stomach, this technique requires a long learning curve and the measured volume is poorly correlated with reference techniques (MRI and 99Tc scintigraphy). Two studies have recently measured intragastric volume by three dimensional ultrasound with promising results.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| volunteers | – | Device: 3D echographyHealthy volunteers over the age of 18 years employed by Amiens University Hospital 3D echography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers fasting
Key inclusion criteria (3 listed)
- Healthy volunteers over the age of 18 years employed by Amiens University Hospital and covered by French national health insurance.
- Fasting (last meal > 6 hours and last drink of water, tea or coffee > 2 hours)
- Signature of the free and informed written consent form.
Key exclusion criteria (4 listed)
- Pregnant woman.
- Presence of diseases or treatments that alter (slow or accelerate) gastric emptying.
- Presence of swallowing disorders.
- History of gastric or supramesocolic surgery.
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 |
|---|---|---|
| 3D echographyultrasound visualization of the stomach in fasting patients. | Device | volunteers |
Primary outcome
success rate of ultrasound visualization of the stomach while fasting
Time frame: Day 0
success rate of ultrasound visualization of the stomach while fasting
4 secondary outcomes
ultrasound visualization of the fasting stomach learning curve
Time frame: Day 0
measured difference of antral surface area
Time frame: Day 0
absolute error of the volume measured
Time frame: Day 0
relative error of the volume measured
Time frame: Day 0
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 30 Jun 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.
Edouard SECQ, PhD principal investigator
CHU Amiens
Emmanuel LORNE, MD, PhD principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Echocardiography, Three-Dimensional, run by Centre Hospitalier Universitaire, Amiens 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 3 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 30 Jun 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?
success rate of ultrasound visualization of the stomach while fasting (time frame: Day 0). 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 30 Jun 2016.