DiabetesECHODIABETENCT03036774
Ultrasound Measure of Gastric Volume in Diabetic and Non Diabetic Patients Before General Anesthesia
A study testing Ultrasonic measurement of antral area in people with Diabetes, run by Hopital Foch at 3 sites in France.
Trial summary
The main objective is to compare the frequency of a " full stomach " in diabetic patients compared with a control population, all the patients having followed the instructions of preoperative fast. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- Ultrasonic measurement of antral area
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- 3 sitesFrance
- Study dates
- 14 Feb 2017to 6 Feb 2019
- 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
- Patients aged over 18
- American Society of Anesthesiologists (ASA) classification 1 to 3
- Needed a general anesthesia for a programmed surgical intervention
- Respect of instructions of the pre-operative fasting;
- Affiliation to the social security;
- Consent form signed
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- Non inclusion Criteria:
- Pregnant or breastfeeding women
- Patients already operated or to be operated from the upper digestive tract (esophagus, stomach, duodenum)
- Patients treated with a prokinetic treatment and / or a level 3 analgesic
Who cannot join
- Unfeasibility to ultrasound measurement of antral area
- Failure to observe fasting instructions
Trial locations and contacts
3 sites in 1 country.
France3 sites
Fondation Ophtalmologique Adolphe de Rotschild
Paris, 75019
AP-HP Hopital Tenon
Paris, 75020
Hopital Foch
Suresnes, 92150
About this study
Official title: Quantitative Ultrasound Assessment of Gastric Volume in Diabetic and Non Diabetic Patients Scheduled for a General Anesthesia
The main objective is to compare the frequency of a " full stomach " in diabetic patients compared with a control population, all the patients having followed the instructions of preoperative fast.
- Conditions
- Diabetes
- Being tested
- Ultrasonic measurement of antral area
- Keywords
- Gastric contents, Ultrasound, Diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonic measurement of antral areaProcedure or surgery
Antral area is measured by ultrasound using a curvilinear abdominal probe of 2-5 MHz and a Logiq E (General Electrics) type echograph or equivalent.
Ultrasound is done before the induction of general anesthesia. Three consecutive measurements of the anteroposterior (AP) and cranio-caudal (CC) diameters are performed.
Antral area (CSA expressed in mm²) is show by the following formula: CSA = AP × CC × π / 4.
Antral area will correspond to the average of the three measures.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic patient | Experimental | Diabetic patients (type 1 or type 2 diabetes) with scheduled surgery . Ultrasonic measurement of antral area Receives: Procedure: Ultrasonic measurement of antral area |
| Non diabetic patient | Other | Patients with scheduled surgery without history of diabetes or a current, treated or untreated, diabetic disease.
Ultrasonic measurement of antral area Receives: Procedure: Ultrasonic measurement of antral area |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with full stomach
The main objective is to compare the frequency of a "full stomach" in the diabetic population compared to a "control" population just before induction of general anesthesia.
A "full stomach" is defined by an antral area > 340 mm2
The main objective is to compare the frequency of a "full stomach" in the diabetic population compared to a "control" population just before induction of general anesthesia.
A "full stomach" is defined by an antral area > 340 mm2
Measured: one day
Secondary outcomes (6)
Glycemia
To assess the relationship between preoperative blood glucose and gastric emptying in the diabetic population
Measured: one day
Fast duration
To compare the impact of the duration of fasting on the gastric residue in both populations of patients (diabetic and non-diabetic)
Measured: one day
Glycated hemoglobin
To assess the relationship between glycated hemoglobin and gastric emptying in the diabetic population
Measured: one day
Evaluation of anxiety using a numerical scale (from 0 -no anxiety- to 10 -maximal anxiety-)
To compare the impact of anxiety on the gastric residue in both populations of patients (diabetic and non-diabetic) in both populations of patients (diabetic and non-diabetic)
Measured: one day
Evaluation of anxiety using a numerical scale (from 0 -no pain- to 10 -maximal pain-)
To compare the impact of pain on the gastric residue in both populations of patients (diabetic and non-diabetic) in both populations of patients (diabetic and non-diabetic)
Measured: one day
Intraoperative hypoxemia
Evaluation of the risk of intraoperative pulmonary inhalation in both populations of patients (diabetic and non-diabetic)
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study start14 Feb 2017
- Primary completion6 Feb 2019
- Study completion6 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien Rousset, MD, Principal investigator, Hôpital TenonMarc Fischler, MD-PhD, Study chair, Hôpital FochFrancis Bonnet, MD-PhD, Study chair, HopitalTenon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03036774
- Sponsor's protocol ID
- 2014/30
- Other IDs
- 2015-A01997-47
- Acronym
- ECHODIABETE
- Status last verified
- Jan 2020
- First submitted
- 27 Jan 2017
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Ultrasound Assessment of Gastric Volume in Diabetic and Non Diabetic Patients Scheduled for a General Anesthesia
- ClinicalTrials.gov ID
- NCT03036774
- Acronym / sponsor ID
- ECHODIABETE / 2014/30
- Conditions
- Diabetes
- Keywords
- Gastric contents, Ultrasound, Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 14 Feb 2017 (actual)
- Primary completion
- 6 Feb 2019 (actual)
- Study completion
- 6 Feb 2019 (actual)
- First posted
- 30 Jan 2017 (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.
The main objective is to compare the frequency of a " full stomach " in diabetic patients compared with a control population, all the patients having followed the instructions of preoperative fast.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic patient | Experimental | Procedure: Ultrasonic measurement of antral areaDiabetic patients (type 1 or type 2 diabetes) with scheduled surgery . Ultrasonic measurement of antral area |
| Non diabetic patient | Other | Procedure: Ultrasonic measurement of antral areaPatients with scheduled surgery without history of diabetes or a current, treated or untreated, diabetic disease. Ultrasonic measurement of antral area |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients aged over 18
- American Society of Anesthesiologists (ASA) classification 1 to 3
- Needed a general anesthesia for a programmed surgical intervention
- Respect of instructions of the pre-operative fasting;
- Affiliation to the social security;
Key exclusion criteria (2 listed)
- Unfeasibility to ultrasound measurement of antral area
- Failure to observe fasting instructions
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 |
|---|---|---|
| Ultrasonic measurement of antral areaAntral area is measured by ultrasound using a curvilinear abdominal probe of 2-5 MHz and a Logiq E (General Electrics) type echograph or equivalent. Ultrasound is done before the induction of general anesthesia. Three consecutive measurements of the anteroposterior (AP) and cranio-caudal (CC) diameters are performed. Antral area (CSA expressed in mm²) is show by the following formula: CSA = AP × CC × π / 4. Antral area will correspond to the average of the three measures. | Procedure or surgery | Diabetic patient, Non diabetic patient |
Primary outcome
Number of patients with full stomach
Time frame: one day
The main objective is to compare the frequency of a "full stomach" in the diabetic population compared to a "control" population just before induction of general anesthesia. A "full stomach" is defined by an antral area > 340 mm2 The main objective is to compare the frequency of a "full stomach" in the diabetic population compared to a "control" population just before induction of general anesthesia. A "full stomach" is defined by an antral area > 340 mm2
6 secondary outcomes
Glycemia
Time frame: one day
Fast duration
Time frame: one day
Glycated hemoglobin
Time frame: one day
Evaluation of anxiety using a numerical scale (from 0 -no anxiety- to 10 -maximal anxiety-)
Time frame: one day
Evaluation of anxiety using a numerical scale (from 0 -no pain- to 10 -maximal pain-)
Time frame: one day
Intraoperative hypoxemia
Time frame: one day
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 14 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Julien Rousset, MD principal investigator
Hôpital Tenon
Marc Fischler, MD-PhD study chair
Hôpital Foch
Francis Bonnet, MD-PhD study chair
HopitalTenon
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonic measurement of antral area in people with Diabetes, run by Hopital Foch at 3 sites 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 10 inclusion and 2 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 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Number of patients with full stomach (time frame: one day). 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 14 Jan 2020.