Gastric UltrasoundECHOmaterNCT04277013
Ultrasound Assessment of Gastric Content in Fasted Pregnant Women
An observational study of Gastric Ultrasound and Fasting ( 6H for Solid ; 2H for Clear Fluid ), run by University Hospital, Montpellier at 1 site in France.
Trial summary
Pulmonary aspiration of gastric content is one of the most feared perioperative complication of general anesthesia. Pregnant women are usually considered as high risk of pulmonary aspiration but there is no epidemiological study evaluating gastric content in pregnant women during the entire gestation periode. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gastric Ultrasound, Fasting ( 6H for Solid ; 2H for Clear Fluid ), Pregnant Women
- How many people
- 1,200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2020to 1 May 2024
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The Investigator would like to perform an ultrasound assessment of gastric content to every fasted pregnant women before surgery or during ultrasound exam happening during standard pregnancy monitoring.
Who may be able to join
- An subject must fulfill all of the following criteria in order to be eligible for study enrollment:
- Aged at least 18 years old
- Pregnant women
- Fasted ( at least 6h for solid , 2h for clear fluid )
Who cannot join
- Previous Bariatric surgery / upper gastro-intestinal surgery
- Adult under protection
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Uhmontpellier
Montpellier, 34295
Fanny Bauchy, MD, 467338256 ext. 33, f-bauchy@chu-montpellier.fr
About this study
Official title: Ultrasound Assessment of Gastric Content in Fasted Pregnant Women : a Prospective Study
Pulmonary aspiration of gastric content is one of the most feared perioperative complication of general anesthesia. Pregnant women are usually considered as high risk of pulmonary aspiration but there is no epidemiological study evaluating gastric content in pregnant women during the entire gestation periode.
The main objective is evaluating prevalency of "full stomach" in differents stages of pregnancy in fasted pregnant women.
Read the detailed description
Subjects will be recruited at Montpellier University Hospital, from fasted pregnant women before surgery or from ultrasound exam performed during pregnancy.
- Keywords
- Anaesthesia, Obstetric, Diagnostic imaging, Stomach, Ultrasonography
- Medical subject headings
- Fasting
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative assessment of gastric content
Qualitative assessment of gastric content using "Perlas Grade
Measured: 1 day
Secondary outcomes (2)
Quantitative assessment of gastric content
Quantitative assessment of gastric content by measuring antral area
Measured: 1 day
Feasibility evaluation of gastric ultrasound
Feasibility evaluation of gastric ultrasound during pregnancy
Measured: pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start1 Mar 2020
- Primary completion1 Mar 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric UltrasoundStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe DADURE, PhD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04277013
- Sponsor's protocol ID
- RECHMPL19_0560
- Acronym
- ECHOmater
- Status last verified
- Jan 2022
- First submitted
- 17 Feb 2020
- Last updated
- 31 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Assessment of Gastric Content in Fasted Pregnant Women : a Prospective Study
- ClinicalTrials.gov ID
- NCT04277013
- Acronym / sponsor ID
- ECHOmater / RECHMPL19_0560
- Keywords
- Anaesthesia, Obstetric, Diagnostic imaging, Stomach, Ultrasonography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 20 Feb 2020 (actual)
- 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.
Pulmonary aspiration of gastric content is one of the most feared perioperative complication of general anesthesia. Pregnant women are usually considered as high risk of pulmonary aspiration but there is no epidemiological study evaluating gastric content in pregnant women during the entire gestation periode.
The main objective is evaluating prevalency of "full stomach" in differents stages of pregnancy in fasted pregnant women.
Detailed description
Subjects will be recruited at Montpellier University Hospital, from fasted pregnant women before surgery or from ultrasound exam performed during pregnancy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The Investigator would like to perform an ultrasound assessment of gastric content to every fasted pregnant women before surgery or during ultrasound exam happening during standard pregnancy monitoring.
Key inclusion criteria (4 listed)
- An subject must fulfill all of the following criteria in order to be eligible for study enrollment:
- Aged at least 18 years old
- Pregnant women
- Fasted ( at least 6h for solid , 2h for clear fluid )
Key exclusion criteria (2 listed)
- Previous Bariatric surgery / upper gastro-intestinal surgery
- Adult under protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Qualitative assessment of gastric content
Time frame: 1 day
Qualitative assessment of gastric content using "Perlas Grade
2 secondary outcomes
Quantitative assessment of gastric content
Time frame: 1 day
Feasibility evaluation of gastric ultrasound
Time frame: pregnancy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2022.
- Individual participant dataSharing planned: Undecided. NC
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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.
Christophe DADURE, PhD study director
University Hospital, Montpellier
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 Gastric Ultrasound and Fasting ( 6H for Solid ; 2H for Clear Fluid ), run by University Hospital, Montpellier 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 4 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: status not confirmed, as of the sponsor's last update on 31 Jan 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fanny Bauchy, MD (467338256 ext. 33, f-bauchy@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative assessment of gastric content (time frame: 1 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 31 Jan 2022.