Gastric UltrasoundNCT03205774
Positioning and Ultrasound Examination of the Gastric Antrum
A study testing 6 hours fasting and free oral intake of water in people with Gastric Ultrasound, run by Hôpital Edouard Herriot at 1 site in France.
Trial summary
The aim of this prospective study was to assess the effect of patient positioning on the ultrasound assessment of gastric contents. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastric Ultrasound
- What is being tested?
- 6 hours fasting and free oral intake of water
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jul 2017to 20 Jan 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA 1 and 2 volunteers
Who cannot join
- Diabetes mellitus
- previous gastrointestinal surgery
- Medication affecting gastric motility
- digestive diseases, gastroparesis
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Positioning on Ultrasound Examination of the Gastric Antrum
The aim of this prospective study was to assess the effect of patient positioning on the ultrasound assessment of gastric contents.
- Conditions
- Gastric Ultrasound
- Being tested
- 6 hours fasting and free oral intake of water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6 hours fasting and free oral intake of waterBehavioural
Ultrasound examination of the gastric antrum are performed in volunteers after prolonged fasting and 10 min after oral intake of water. Volunteer should be lying on his/her back, right lateral decubitus position and left lateral decubitus position with randomization of the order.
| Study group | Role | What they receive |
|---|---|---|
| Supine position | Sham comparator | patient in supine position, lying on the back, turned in the right lateral decubitus and turned in the left lateral decubitus in a randomized way, after prolonged fasting and 10 min after free oral intake of water Receives: Behavioral: 6 hours fasting and free oral intake of water |
| 30° semirecumbent position | Sham comparator | patient in semirecumbent position (head of the bed elevated to 30°), lying on the back, turned in the right lateral decubitus and turned in the left lateral decubitus in a randomized way, after prolonged fasting and 10 min after free oral intake of water Receives: Behavioral: 6 hours fasting and free oral intake of water |
| 45° semirecumbent position | Sham comparator | patient in semirecumbent position (head of the bed elevated to 45°), lying on the back, turned in the right lateral decubitus and turned in the left lateral decubitus in a randomized way, after prolonged fasting and 10 min after free oral intake of water Receives: Behavioral: 6 hours fasting and free oral intake of water |
| 90° semirecumbent position | Sham comparator | patient in semirecumbent position (head of the bed elevated to 90°), lying on the back, after prolonged fasting and 10 min after free oral intake of water Receives: Behavioral: 6 hours fasting and free oral intake of water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ultrasound measurement of the antral cross sectional area according to the position
Ultrasound measurement of antral cross-sectional area
Measured: through study completion, an average of 20 min
Change in qualitative ultrasound assessment of gastric contents according to the position
qualitative ultrasound assessment of gastric contents
Measured: through study completion, an average of 20 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start3 Jul 2017
- Primary completion20 Jan 2018
- Study completion20 Jan 2018
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Edouard Herriot
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lionel Bouvet, Hôpital Edouard Herriot
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03205774
- Sponsor's protocol ID
- L16-190
- Status last verified
- May 2018
- First submitted
- 28 Jun 2017
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Positioning on Ultrasound Examination of the Gastric Antrum
- ClinicalTrials.gov ID
- NCT03205774
- Acronym / sponsor ID
- L16-190
- Conditions
- Gastric Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Hôpital Edouard HerriotUniversity, hospital or other
- Study start
- 3 Jul 2017 (actual)
- Primary completion
- 20 Jan 2018 (actual)
- Study completion
- 20 Jan 2018 (actual)
- First posted
- 2 Jul 2017 (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.
The aim of this prospective study was to assess the effect of patient positioning on the ultrasound assessment of gastric contents.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Supine position | Sham comparator | Behavioral: 6 hours fasting and free oral intake of waterpatient in supine position, lying on the back, turned in the right lateral decubitus and turned in the left lateral decubitus in a randomized way, after prolonged fasting and 10 min after free oral intake of water |
| 30° semirecumbent position | Sham comparator | Behavioral: 6 hours fasting and free oral intake of waterpatient in semirecumbent position (head of the bed elevated to 30°), lying on the back, turned in the right lateral decubitus and turned in the left lateral decubitus in a randomized way, after prolonged fasting and 10 min after free oral intake of water |
| 45° semirecumbent position | Sham comparator | Behavioral: 6 hours fasting and free oral intake of waterpatient in semirecumbent position (head of the bed elevated to 45°), lying on the back, turned in the right lateral decubitus and turned in the left lateral decubitus in a randomized way, after prolonged fasting and 10 min after free oral intake of water |
| 90° semirecumbent position | Sham comparator | Behavioral: 6 hours fasting and free oral intake of waterpatient in semirecumbent position (head of the bed elevated to 90°), lying on the back, after prolonged fasting and 10 min after free oral intake of water |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA 1 and 2 volunteers
Key exclusion criteria (5 listed)
- Diabetes mellitus
- previous gastrointestinal surgery
- Medication affecting gastric motility
- digestive diseases, gastroparesis
- Pregnancy
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 |
|---|---|---|
| 6 hours fasting and free oral intake of waterUltrasound examination of the gastric antrum are performed in volunteers after prolonged fasting and 10 min after oral intake of water. Volunteer should be lying on his/her back, right lateral decubitus position and left lateral decubitus position with randomization of the order. | Behavioural | 30° semirecumbent position, 45° semirecumbent position, 90° semirecumbent position, Supine position |
Primary outcome
Change in ultrasound measurement of the antral cross sectional area according to the position
Time frame: through study completion, an average of 20 min
Ultrasound measurement of antral cross-sectional area
Change in qualitative ultrasound assessment of gastric contents according to the position
Time frame: through study completion, an average of 20 min
qualitative ultrasound assessment of gastric contents
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 7 May 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6 hours fasting and free oral intake of water in people with Gastric Ultrasound, run by Hôpital Edouard Herriot 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 1 inclusion and 5 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 7 May 2018. 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. Some participants in this study may receive a placebo. 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?
Change in ultrasound measurement of the antral cross sectional area according to the position (time frame: through study completion, an average of 20 min). The study lists 2 primary outcomes in all. 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 7 May 2018.